FDA event 93237 · Recall Observatory

device · product 1 of 9

Ventlab, LLC AirFlow manual resuscitator devices with integrated manometer, multiple accessory configurations to include: 1. AirFlow Adult Resuscitator REF #s: AF1140MB-M5, AF1140MB-D5, AF5142OB, AF5142MB, AF5142MB-D235, AF1142MBP, AF5142MBP, AF5140MB, AF5140MB-2, AF5140MB-D6, AF5140MB-F, AF1140MB-T, AF1140MB-PW, AF5140MB-PW, AF1140MB-I, AF5140MB-I, AF5140MBN, AF1140MBS, AF5140MBS, AF1140MB-X, AF5140MB-X, AF1140MB-P, AF5140MBP, AF1140MB-K, AF5140MBS-I,AF5140MBPF-G10, AF5140MBP-G10, AF1140MBP-T, AF5140MBP-I, AF1140MBP-K, AF1140MBC-N, AF1140MBP-2, AF1140MC, AF5140MC, AF1140MCP, AF5140MC-P, AF1100MB, AF5100MB, AF5100MC, AF1140MC-M5, AF1140MB-TM5, AF1140MBP-TM5, AF1100MC, AF1140OB, AF1140MBP-M5, AFW1140MB,AF1140MBS-P, AF1000MBN-20, AF5102MBP, AF1100MB-N, AF1100MC-P, AF1140MB, AF1140MB-E, AF1140MB-N, AF1140MB-R, AF1140MBS-K, AF1140MBSP-I, AF1142MB, AF1100MBS, AF1100MB-MMC, AF1100MB-PWG1, AF1100MBP; 2. AirFlow Child Resuscitator REF #s: AF4100MCP, AF4140MB, AF4140MB-I, AF4140MBP, AF4140MB-PI, AF4100MB, AF4100MBP, AF4100OB, AF4140MB-D23, AF4140OBP, AF4140MCP-D3, AF4140MC; 3. AirFlow Infant Resuscitator REF #s: AF3140OB, AF3144MB, AF3104MB-PW, AF3100MBP- M0D1, AF3100MBP- M012, AF3140MB-M000, AF3140MB-D2, AF3140MB-D1, AF3140MB-S1, AF3140MB-2B, AF3140MB-I, AF3140MB-K, AF3100MB-PW, AF3100MB-PTS1, AF3100MB-M0- D1, AF3100OC, AF3100MC-2, AF3100MC, AF3106MC-2, AF3140MCP-K, AF3140MC-2B, AF3100MCP-2, AF3140MC- M0D12, AF3144MCP- M1M00, AF3100OB, AF3140MB, AF3140MB-M0, AF3140MB-2, AF3140MB-M1, AF3140MB-PW, AF3140MB-P, AF3140MB-D12I, AF3140MBP-2, AF3140MC, AF3140MCP, AF3140MCPF, AF3100MB, AF3100MB-M0, AF3100MB-2, AF3100MB-M1, AF3100MB-X, AF3100MBP, AF3100MB-M01, AF3100MBP-M01, AF3100MBP-2, AF3100MBP-D12, AF3100MCP; 4. AirFlow Pediatric Resuscitator REF #s: AF2100OB, AF2100MB-3, AF2102OB, AF2100MB-D5, AF2140OB, AF2102MBP-2, AF2102MBPW-D4, AF2102MBP-M3, AF2140MB-2, AFW2142OB, AF2140MB-D4, AF2140MB-D43, AF2140MB-P2, AF2144MB, AFW2142MB-2, AF2142MB-D3, AF2242MBP, AF2142MBS-I, AF2142MBP- 224OT, AF2140MBPW- D23, AF2140MB-I, AF2140MB-K, AF2140MB-S, AF2140MBP-K, AF2100MB-PW, AF2100MB-MMC, AF2102MBP, AF2100MB- PWTS4, AF2140MCPF, AF2100MC, AF2102MC, AF2142MC-M01, AF2140MC, AF2142MC-D34, AF2140MCP-D4, AF2140MC-PT, AF2140MCP-K, AF2142MCP, AF2100MCP, AF2102MB, AF2102MCP, AF2102MC-PT, AF2142OB, AF2142OBNS, AF2142MB, AF2142MB-3, AF2142MB-2, AF2142MB-M5E, AF2142MB-PW, AF2142MBP, AF2142MB-K, AF2142MBP-2, AF2142MC-3, AF2142MCP-D4, AF2140MB, AF2140MB-PW, AF2140MBP, AF1142OB, AF2100MB; 5. AirFlow Small Adult Resuscitator REF #s: AF5140MC-D6, AF5140MB-M5, AF5100MB-D5, AF5142MBP-M5, AF5140MBPW-D5, AF5140MBPWTD5, AF5140MBP-D5, AF5140MBP-D6, AF5140MBPW- M5, AF5140MBP-M5, AFN5140MB, AF5140MB-OT, AF5140MB-T, AFD5140MB-T, AF5140MB-K, AF5140MBS-R, AF5140MBS-P, AF5140MB-PT, AF5140MB-ST, AF5140MCP-K, AF5100MB-PW, AF5102MB-N, AF5140MBS-M5. 6. Ventlab, LLC Resuscitation Kit REF # MC1000.

Z-0361-2024

Recall number: Z-0361-2024
Initiated: October 11, 2023
Classification: Class II
Status: Ongoing
Recalling firm: SunMed Holdings, LLC
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

Code information

UDI-DI: 10889483075814 (Item # AF1000MBN-20, Case UDI: 30889483075818); UDI-DI: 10889483076606 (Item # AF1100MB, Case UDI: 30889483076600); UDI-DI: 10889483076613 (Item # AF1100MB-MMC, Case UDI: 30889483076617); UDI-DI: 10889483075838 (Item # AF1100MB-N, Case UDI: 30889483075832); UDI-DI: 10889483088074 (Item # AF1100MBP, Case UDI: 30889483088078); UDI-DI: 10889483086209 (Item # AF1100MB-PWG1, Case UDI: 30889483086203); UDI-DI: 10889483086216 (Item # AF1100MBS, Case UDI: 30889483086210); UDI-DI: 10889483094365 (Item # AF1100MC, Case UDI: 30889483094369); UDI-DI: 10889483159217 (Item # AF1100MC-P, Case UDI: 30889483159211); UDI-DI: 10889483071809 (Item # AF1140MB, Case UDI: 30889483071803); UDI-DI: 10889483230626 (Item # AF1140MBC-N Case UDI: 30889483230620); UDI-DI: 10889483090718 (Item # AF1140MB-D5, Case UDI: 30889483090712); UDI-DI: 10889483106372 (Item # AF1140MB-E, Case UDI: 30889483106376); UDI-DI: 10889483095096 (Item # AF1140MB-I, Case UDI: 30889483095090); UDI-DI: 10889483083918 (Item # AF1140MB-K, Case UDI: 30889483083912); UDI-DI: 10889483162224 (Item # AF1140MB-M5, Case UDI: 30889483162228); UDI-DI: 10889483094372 (Item # AF1140MB-N, Case UDI: 30889483094376); UDI-DI: 10889483098370 (Item # AF1140MB-P, Case UDI: 30889483098374); UDI-DI: 10889483101469 (Item # AF1140MBP-2, Case UDI: 30889483101463); UDI-DI: 10889483106396 (Item # AF1140MBP-K, Case UDI: 30889483106390); UDI-DI: 10889483076637 (Item # AF1140MBP-M5, Case UDI: 30889483076631); UDI-DI: 10889483078143 (Item # AF1140MBP-T, Case UDI: 30889483078147); UDI-DI: 10889483162637 (Item # AF1140MBP-TM5, Case UDI: 30889483162631); UDI-DI: 10889483098387 (Item # AF1140MB-PW, Case UDI: 30889483098381); UDI-DI: 10889483074190 (Item # AF1140MB-R, Case UDI: 30889483074194); UDI-DI: 10889483095119 (Item # AF1140MBS, Case UDI: 30889483095113); UDI-DI: 10889483093320 (Item # AF1140MBS-K, Case UDI: 30889483093324); UDI-DI: 10889483076422 (Item # AF1140MBS-P, Case UDI: 30889483076426); UDI-DI: 10889483089088 (Item # AF1140MBSP-I, Case UDI: 30889483089082); UDI-DI: 10889483087213 (Item # AF1140MB-T, Case UDI: 30889483087217); UDI-DI: 10889483162439 (Item # AF1140MB-TM5, Case UDI: 30889483162433); UDI-DI: 10889483227589 (Item # AF1140MB-X, Case UDI: 30889483227583); UDI-DI: 10889483101476 (Item # AF1140MC, Case UDI: 30889483101470); UDI-DI: 10889483163146 (Item # AF1140MC-M5, Case UDI: 30889483163140); UDI-DI: 10889483097359 (Item # AF1140MCP, Case UDI: 30889483097353); UDI-DI: 10889483102121 (Item # AF1140OB, Case UDI: 30889483102125); UDI-DI: 10889483078150 (Item # AF1142MB, Case UDI: 30889483078154); UDI-DI: 10889483089255 (Item # AF1142MBP, Case UDI: 30889483089259); UDI-DI: 10889483089095 (Item # AF1142OB, Case UDI: 30889483089099); UDI-DI: 10889483096390 (Item # AF2100MB, Case UDI: 30889483096394); UDI-DI: 10889483076019 (Item # AF2100MB-3, Case UDI: 30889483076013); UDI-DI: 10889483171578 (Item # AF2100MB-D5, Case UDI: 30889483171572); UDI-DI: 10889483078181 (Item # AF2100MB-MMC, Case UDI: 30889483078185); UDI-DI: 10889483159231 (Item # AF2100MB-PW, Case UDI: 30889483159235); UDI-DI: 10889483102138 (Item # AF2100MB- PWTS4, Case UDI: 30889483102132); UDI-DI: 10889483090749 (Item # AF2100MC, Case UDI: 30889483090743); UDI-DI: 10889483101506 (Item # AF2100MCP, Case UDI: 30889483101500); UDI-DI: 10889483095706 (Item # AF2100OB, Case UDI: 30889483095700); UDI-DI: 10889483098394 (Item # AF2102MB, Case UDI: 30889483098398); UDI-DI: 10889483112977 (Item # AF2102MBP, Case UDI: 30889483112971); UDI-DI: 10889483076644 (Item # AF2102MBP-2, Case UDI: 30889483076648); UDI-DI: 10889483097304 (Item # AF2102MBP-M3, Case UDI: 30889483097308); UDI-DI: 10889483172285 (Item # AF2102MBPW-D4, Case UDI: 30889483172289); UDI-DI: 10889483158883 (Item # AF2102MC, Case UDI: 30889483158887); UDI-DI: 10889483078198 (Item # AF2102MCP, Case UDI: 30889483078192); UDI-DI: 10889483085769 (Item # AF2102MC-PT, Case UDI: 30889483085763); UDI-DI: 10889483077924 (Item # AF2102OB, Case UDI: 20889483077921); UDI-DI: 10889483078068 (Item # AF2140MB, Case UDI: 30889483078062); UDI-DI: 10889483081143 (Item # AF2140MB-2, Case UDI: 30889483081147); UDI-DI: 10889483076286 (Item # AF2140MB-D4, Case UDI: 30889483076280); UDI-DI: 10889483112984 (Item # AF2140MB-D43, Case UDI: 30889483112988); UDI-DI: 10889483077566 (Item # AF2140MB-I, Case UDI: 20889483077563); UDI-DI: 10889483081150 (Item # AF2140MB-K, Case UDI: 20889483081157); UDI-DI: 10889483088111 (Item # AF2140MBP, Case UDI: 30889483088115); UDI-DI: 10889483096413 (Item # AF2140MB-P2, Case UDI: 30889483096417); UDI-DI: 10889483083734 (Item # AF2140MBP-K, Case UDI: 30889483083738); UDI-DI: 10889483077573 (Item # AF2140MB-PW, Case UDI: 30889483077577); UDI-DI: 10889483159309 (Item # AF2140MBPW- D23, Case UDI: 30889483159303); UDI-DI: 10889483100424 (Item # AF2140MB-S, Case UDI: 30889483100428); UDI-DI: 10889483097311 (Item # AF2140MC, Case UDI: 20889483097318); UDI-DI: 10889483163344 (Item # AF2140MCP-D4, Case UDI: 30889483163348); UDI-DI: 10889483275788 (Item # AF2140MCPF, Case UDI: 30889483275782); UDI-DI: 10889483158821 (Item # AF2140MCP-K, Case UDI: 30889483158825); UDI-DI: 10889483159347 (Item # AF2140MC-PT, Case UDI: 30889483159341); UDI-DI: 10889483085776 (Item # AF2140OB, Case UDI: 30889483085770); UDI-DI: 10889483090237 (Item # AF2142MB , Case UDI: 30889483090231); UDI-DI: 10889483081167 (Item # AF2142MB-2, Case UDI: 30889483081161); UDI-DI: 10889483077931 (Item # AF2142MB-3, Case UDI: 30889483077935); UDI-DI: 10889483087756 (Item # AF2142MB-D3, Case UDI: 30889483087750); UDI-DI: 10889483088128 (Item # AF2142MB-K, Case UDI: 20889483088125); UDI-DI: 10889483102978 (Item # AF2142MBP, Case UDI: 30889483102972); UDI-DI: 10889483073315 (Item # AF2142MBP-2, Case UDI: 30889483073319); UDI-DI: 10889483097328 (Item # AF2142MBP- 224OT, Case UDI: 20889483097325); UDI-DI: 10889483102961 (Item # AF2142MB-PW, Case UDI: 20889483102968); UDI-DI: 10889483081174 (Item # AF2142MBS-I, Case UDI: 30889483081178); UDI-DI: 10889483081181 (Item # AF2142MC-3 , Case UDI: 30889483081185); UDI-DI: 10889483164136 (Item # AF2142MC-D34, Case UDI: 30889483164130); UDI-DI: 10889483168554 (Item # AF2142MC-M01, Case UDI: 30889483168558); UDI-DI: 10889483087800, (Item # AF2142MCP, Case UDI: 30889483087804); UDI-DI: 10889483167083 (Item # AF2142MCP-D4, Case UDI: 30889483167087); UDI-DI: 10889483089262 (Item # AF2142OB, Case UDI: 30889483089266); UDI-DI: 10889483226285 (Item # AF2142OBNS, Case UDI: 30889483226289); UDI-DI: 10889483078204 (Item # AF2144MB, Case UDI: 20889483078201); UDI-DI: 10889483555675 (Item # AF2142MB-M5E, Case UDI: 30889483555679); UDI-DI: 10889483077948 (Item # AF2242MBP, Case UDI: 20889483077945); UDI-DI: 10889483093542 (Item # AF3100MB, Case UDI: 30889483093546); UDI-DI: 10889483165171 (Item # AF3100MB-2, Case UDI: 30889483165175); UDI-DI: 10889483164556 (Item # AF3100MB-M0, Case UDI: 30889483164550); UDI-DI: 10889483085790 (Item # AF3100MB-M01, Case UDI: 20889483085797); UDI-DI: 10889483100431 (Item # AF3100MB-M0- D1, Case UDI: 30889483100435); UDI-DI: 10889483103432 (Item # AF3100MB-M1, Case UDI: 30889483103436); UDI-DI: 10889483089293 (Item # AF3100MBP, Case UDI: 30889483089297); UDI-DI: 10889483172254 (Item # AF3100MBP-2, Case UDI: 30889483172258); UDI-DI: 10889483159323 (Item # AF3100MBP-D12, Case UDI: 30889483159327); UDI-DI: 10889483083741 (Item # AF3100MBP-M01 Case UDI: 30889483083745 UDI-DI: 10889483158807 (Item # AF3100MBP- M012, Case UDI: 30889483158801); UDI-DI: 10889483165188 (Item # AF3100MBP- M0D1, Case UDI: 30889483165182); UDI-DI: 10889483087770 (Item # AF3100MB-PTS1, Case UDI: 30889483087774); UDI-DI: 10889483097335 (Item # AF3100MB-PW, Case UDI: 30889483097339); UDI-DI: 10889483228708 (Item # AF3100MB-X, Case UDI: 30889483228702); UDI-DI: 10889483081198 (Item # AF3100MC, Case UDI: 20889483081195); UDI-DI: 10889483077108 (Item # AF3100MC-2, Case UDI: 20889483077105); UDI-DI: 10889483089309 (Item # AF3100MCP, Case UDI: 30889483089303); UDI-DI: 10889483107447 (Item # AF3100MCP-2, Case UDI: 30889483107441); UDI-DI: 10889483075517 (Item # AF3100OB, Case UDI: 20889483075514); UDI-DI: 10889483097397 (Item # AF3100OC, Case UDI: 20889483097394); UDI-DI: 10889483172629 (Item # AF3104MB-PW, Case UDI: 30889483172623); UDI-DI: 10889483080023 (Item # AF3106MC-2, Case UDI: 30889483080027); UDI-DI: 10889483095713 (Item # AF3140MB, Case UDI: 30889483095717); UDI-DI: 10889483087220 (Item # AF3140MB-2, Case UDI: 30889483087224); UDI-DI: 10889483077115 (Item # AF3140MB-2B, Case UDI: 30889483077119); UDI-DI: 10889483078099 (Item # AF3140MB-D1, Case UDI: 30889483078093); UDI-DI: 10889483102985 (Item # AF3140MB-D12I, Case UDI: 30889483102989); UDI-DI: 10889483097342 (Item # AF3140MB-D2, Case UDI: 30889483097346); UDI-DI: 10889483087824 (Item # AF3140MB-I, Case UDI: 30889483087828); UDI-DI: 10889483103449 (Item # AF3140MB-K, Case UDI: 30889483103443); UDI-DI: 10889483077214 (Item # AF3140MB-M0, Case UDI: 30889483077218); UDI-DI: 10889483082683 (Item # AF3140MB-M000, Case UDI: 30889483082687); UDI-DI: 10889483102992 (Item # AF3140MB-M1, Case UDI: 30889483102996); UDI-DI: 10889483113011 (Item # AF3140MB-P, Case UDI: 30889483113015); UDI-DI: 10889483096444 (Item # AF3140MBP-2, Case UDI: 30889483096448); UDI-DI: 10889483159910 (Item # AF3140MB-PW, Case UDI: 30889483159914); UDI-DI: 10889483090299 (Item # AF3140MB-S1, Case UDI: 30889483090293); UDI-DI: 10889483079256 (Item # AF3140MC, Case UDI: 30889483079250); UDI-DI: 10889483077597 (Item # AF3140MC-2B, Case UDI: 30889483077591); UDI-DI: 10889483232088 (Item # AF3140MC- M0D12 UDI-DI: 10889483166963 (Item # AF3140MCP, Case UDI: 30889483166967); UDI-DI: 10889483275771 (Item # AF3140MCPF, Case UDI: 30889483275775); UDI-DI: 1088948315881 (Item # AF3140MCP-K, Case UDI: 30889483158818); UDI-DI: 10889483097410 (Item # AF3140OB, Case UDI: 30889483097414); UDI-DI: 10889483078105 (Item # AF3144MB, Case UDI: 30889483078109); UDI-DI: 10889483272626 (Item # AF3144MCP- M1M00, Case UDI: 30889483272620); UDI-DI: 10889483090305 (Item # AF4100MB, Case UDI: 30889483090309); UDI-DI: 10889483160121 (Item # AF4100MBP, Case UDI: 30889483160125); UDI-DI: 10889483182246 (Item # AF4100MCP, Case UDI: 30889483182240); UDI-DI: 10889483098417 (Item # AF4100OB, Case UDI: 30889483098411); UDI-DI: 10889483077627 (Item # AF4140MB, Case UDI: 30889483077621); UDI-DI: 10889483090510 (Item # AF4140MB-D23, Case UDI: 30889483090514); UDI-DI: 10889483093559 (Item # AF4140MB-I, Case UDI: 30889483093553); UDI-DI: 10889483099209 (Item # AF4140MBP, Case UDI: 30889483099203); UDI-DI: 10889483079287 (Item # AF4140MB-PI, Case UDI: 30889483079281); UDI-DI: 10889483087237 (Item # AF4140MC, Case UDI: 30889483087231); UDI-DI: 10889483163337 (Item # AF4140MCP-D3, Case UDI: 30889483163331); UDI-DI: 10889483090527 (Item # AF4140OBP, Case UDI: 30889483090521); UDI-DI: 10889483089323 (Item # AF5100MB, Case UDI: 30889483089327); UDI-DI: 10889483089330 (Item # AF5100MB-D5, Case UDI: 30889483089334); UDI-DI: 10889483159224 (Item # AF5100MB-PW, Case UDI: 30889483159228); UDI-DI: 10889483099346 (Item # AF5100MC, Case UDI: 30889483099340); UDI-DI: 10889483171929 (Item # AF5102MB-N, Case UDI: 30889483171923); UDI-DI: 10889483165164 (Item # AF5102MBP, Case UDI: 30889483165168); UDI-DI: 10889483103012 (Item # AF5140MB, Case UDI: 30889483103016); UDI-DI: 10889483079881 (Item # AF5140MB-2, Case UDI: 30889483079885); UDI-DI: 10889483089606 (Item # AF5140MB-D6, Case UDI: 30889483089600); UDI-DI: 10889483083758 (Item # AF5140MB-F, Case UDI: 30889483083752); UDI-DI: 10889483087251 (Item # AF5140MB-I, Case UDI: 30889483087255); UDI-DI: 10889483082720 (Item # AF5140MB-K, Case UDI: 30889483082724); UDI-DI: 10889483162408 (Item # AF5140MB-M5, Case UDI: 30889483162402); UDI-DI: 10889483090275 (Item # AF5140MBN, Case UDI: 30889483090279); UDI-DI: 10889483103029 (Item # AF5140MB-OT, Case UDI: 30889483103023); UDI-DI 10889483074725 (Item # AF5140MBP, Case UDI: 30889483074729 UDI-DI: 10889483098431 (Item # AF5140MBP-D5, Case UDI: 30889483098435); UDI-DI: 10889483104682 (Item # AF5140MBP-D6, Case UDI: 30889483104686); UDI-DI: 10889483275757 (Item # AF5140MBPF-G10, Case UDI: 30889483275751); UDI-DI: 10889483171967 (Item # AF5140MBP-G10, Case UDI: 30889483171961); UDI-DI: 10889483072233 (Item # AF5140MBP-I , Case UDI: 30889483072237); UDI-DI: 10889483163085 (Item # AF5140MBP-M5, Case UDI: 30889483163089); UDI-DI: 10889483089347 (Item # AF5140MB-PT, Case UDI: 30889483089341); UDI-DI: 10889483080061 (Item # AF5140MB-PW, Case UDI: 30889483080065); UDI-DI: 10889483099216 (Item # AF5140MBPW-D5, Case UDI: 30889483099210); UDI-DI: 10889483162514 (Item # AF5140MBPW- M5, Case UDI: 30889483162518); UDI-DI: 10889483079133 (Item # AF5140MBPWTD5, Case UDI: 30889483079137); UDI-DI: 10889483083772 (Item # AF5140MBS, Case UDI: 30889483083776); UDI-DI: 10889483077139 (Item # AF5140MBS-I, Case UDI: 30889483077133); UDI-DI: 10889483162231 (Item # AF5140MBS-M5, Case UDI: 30889483162235); UDI-DI: 10889483087268 (Item # AF5140MBS-P, Case UDI: 30889483087262); UDI-DI: 10889483083789 (Item # AF5140MBS-R, Case UDI: 30889483083783); UDI-DI: 10889483092682 (Item # AF5140MB-ST, Case UDI: 30889483092686); UDI-DI: 10889483083765 (Item # AF5140MB-T, Case UDI: 30889483083769); UDI-DI: 10889483227619 (Item # AF5140MB-X, Case UDI: 30889483227613); UDI-DI: 10889483090282 (Item # AF5140MC, Case UDI: 30889483090286); UDI-DI: 10889483228241 (Item # AF5140MC-D6, Case UDI: 30889483228245); UDI-DI: 10889483104200 (Item # AF5140MC-P, Case UDI: 30889483104204); UDI-DI: 10889483158838 (Item # AF5140MCP-K, Case UDI: 30889483158832); UDI-DI: 10889483089613 (Item # AF5142MB, Case UDI: 30889483089617); UDI-DI: 10889483227305 (Item # AF5142MB-D235, Case UDI: 30889483227309); UDI-DI: 10889483091838 (Item # AF5142MBP, Case UDI: 30889483091832); UDI-DI: 10889483163177 (Item # AF5142MBP-M5, Case UDI: 30889483163171); UDI-DI: 10889483080078 (Item # AF5142OB, Case UDI: 30889483080072); UDI-DI: 10889483085127 (Item # AFD5140MB-T, Case UDI: 30889483085121); UDI-DI: 10889483162781 (Item # AFN5140MB, Case UDI: 30889483162785); UDI-DI: 10889483099247 (Item # AFW1140MB, Case UDI: 30889483099241 UDI-DI: 10889483092705 (Item# AFW2142MB-2, Case UDI: 30889483092709); UDI-DI: 10889483078709 (Item # AFW2142OB, Case UDI: 30889483078703). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

Distribution pattern

US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.

device · product 2 of 9

Ventlab, LLC BreathTech manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. BreathTech Adult Resuscitator REF #s: BT5107F & BT5104P; 2. BreathTech Child Resuscitator REF #s: BT3030, BT3034, & BT3025; 3. BreathTech Infant Resuscitator REF #s: BT2415K, BT2416, BT2032, BT2016, BT2035, BT2216, BT2036, BT2023, BT2026, BT2220-2, BT2020, BT2220, BT2220F, BT2215, BT2415, BT2014, BT2027, BT2015, BT2029, BT2037, BT2048, BT2034, BT2034W, BT2234, BT2234FK; 4. BreathTech Pediatric Resuscitator REF #s: BT4016, BT4019, BT4013, BT4018, BT4013F, BT4015, BT4006-N, BT4040, BT4022, BT4045, BT4024.

Z-0362-2024

Recall number: Z-0362-2024
Initiated: October 11, 2023
Classification: Class II
Status: Ongoing
Recalling firm: SunMed Holdings, LLC
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

Code information

UDI-DI: 10889483090787 (Item # BT2014, Case UDI: 30889483090781); UDI-DI: 10889483102046 (Item # BT2015, Case UDI: 30889483102040); UDI-DI: 10889483097830 (Item # BT2016, Case UDI: 30889483097834); UDI-DI: 10889483083246 (Item # BT2020, Case UDI: 30889483083240); UDI-DI: 10889483083253 (Item # BT2023, Case UDI: 30889483083257); UDI-DI: 10889483086339 (Item # BT2026, Case UDI: 30889483086333); UDI-DI: 10889483091050 (Item # BT2027, Case UDI: 30889483091054); UDI-DI: 10889483076170 (Item # BT2029, Case UDI: 30889483076174); UDI-DI: 10889483077764 (Item # BT2032, Case UDI: 30889483077768); UDI-DI: 10889483080108 (Item # BT2034, Case UDI: 30889483080102); UDI-DI: 10889483080573 (Item # BT2034W, Case UDI: 30889483080577); UDI-DI: 10889483092880 (Item # BT2035, Case UDI: 30889483092884); UDI-DI: 10889483090794 (Item # BT2036, Case UDI: 30889483090798); UDI-DI: 10889483083277 (Item # BT2037, Case UDI: 30889480832771); UDI-DI: 10889483078853 (Item # BT2048, Case UDI: 30889483078857); UDI-DI: 10889483106037 (Item # BT2215, Case UDI: 30889483106031); UDI-DI: 10889483101148 (Item # BT2216, Case UDI: 30889483101142); UDI-DI: 10889483100868 (Item # BT2220, Case UDI: 30889483100862); UDI-DI: 10889483080115 (Item # BT2220-2, Case UDI: 30889483080119); UDI-DI: 10889483088999 (Item # BT2220F, Case UDI: 30889483088993); UDI-DI: 10889483080580 (Item # BT2234, Case UDI: 30889483080584); UDI-DI: 10889483103357 (Item # BT2234FK, Case UDI: 30889483103351); UDI-DI: 10889483090800 (Item # BT2415, Case UDI: 30889483090804); UDI-DI: 10889483086346 (Item # BT2415K, Case UDI: 30889483086340); UDI-DI: 10889483080122 (Item # BT2416, Case UDI: 30889483080126); UDI-DI: 10889483109168 (Item # BT3025, Case UDI: 30889483109162); UDI-DI: 10889483099780 (Item # BT3030, Case UDI: 30889483099784); UDI-DI: 10889483096253 (Item # BT3034, Case UDI: 30889483096257); UDI-DI: 10889483080634 (Item # BT4006-N, Case UDI: 20889483080631); UDI-DI: 10889483091272 (Item # BT4013, Case UDI: 30889483091276); UDI-DI: 10889483160527 (Item # BT4013F, Case UDI: 30889483160521); UDI-DI: 10889483106068 (Item # BT4015, Case UDI: 30889483106062); UDI-DI: 10889483102541 (Item # BT4016, Case UDI: 30889483102545); UDI-DI: 10889483113080 (Item # BT4018, Case UDI: 30889483113084); UDI-DI: 10889483109175 (Item # BT4019, Case UDI: 20889483109172); UDI-DI: 10889483079317 (Item # BT4022, Case UDI: 30889483079311); UDI-DI: 10889483084915 (Item # BT4024, Case UDI: 30889483084919); UDI-DI: 10889483097571 (Item # BT4040, Case UDI: 30889483097575); UDI-DI: 10889483079324 (Item # BT4045, Case UDI: 30889483079328); UDI-DI: 10889483165867 (Item # BT5104P, Case UDI: 30889483165861); UDI-DI: 10889483165843 (Item # BT5107F, Case UDI: 30889483165823). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

Distribution pattern

US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.

device · product 3 of 9

Ventlab, LLC Horizon manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Horizon Adult Resuscitator REF #s: 9122HZ, HZI9000, HZI9108, 9106HZ, 9110HZ, 9120HZ, 9111HZ, 9100HZ, 9105HZ, 9108HZ, 9006HZ, 9002HZ; 2. Horizon Infant Resuscitator REF #s: 6112HZ, 6123HZ, 6125HZ, 6200HZ, 6106HZ, 6118HZ, 6107HZ, 6013HZ, 6117HZ, 6116HZ, 6019HZ, HZI6000, 6009HZ; 3. Horizon Pediatric Resuscitator REF #s: 8106HZ, 8119HZ, 8115HZ, 8107HZ, 8010HZ, 8004HZ, 8105HZ, 8113HZ, 8109HZ, 8116HZ, 8003HZ, HZI8100;

Z-0363-2024

Recall number: Z-0363-2024
Initiated: October 11, 2023
Classification: Class II
Status: Ongoing
Recalling firm: SunMed Holdings, LLC
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

Code information

UDI-DI: 10889483166611 (Item # 6009HZ, Case UDI: 30889483166615) UDI-DI: 10889483167786 (Item#: 6013HZ, Case UDI: 30889483167780) UDI-DI: 10889483170786 (Item#: 6019HZ, Case UDI: 30889483170780) UDI-DI: 10889483166437 (Item#: 6106HZ, Case UDI: 30889483166431) UDI-DI: 10889483166444 (Item#: 6107HZ, Case UDI: 30889483166448) UDI-DI: 10889483166499 (Item#: 6112HZ, Case UDI: 30889483166493) UDI-DI: 10889483167779 (Item#:6116HZ, Case UDI: 30889483167773) UDI-DI: 10889483167885 (Item#: 6117HZ, Case UDI: 30889483167889) UDI-DI: 10889483168233 (Item # 6118HZ, Case UDI: 30889483168237) UDI-DI: 10889483170199 (Item # 6123HZ, Case UDI: 30889483170193) UDI-DI: 10889483171189 (Item # 6125HZ, Case UDI: 30889483171183) UDI-DI: 10889483170984 (Item # 6200HZ, Case UDI: 30889483170988) UDI-DI: 10889483166680 (Item # 8003HZ, Case UDI: 30889483166684) UDI-DI: 10889483166697 (Item # 8004HZ, Case UDI: 30889483166691) UDI-DI: 10889483230831(Item # 8010HZ, Case UDI: 30889483230834) UDI-DI: 10889483172650 (Item # 8105HZ, Case UDI: 30889483172654) UDI-DI: 10889483166741(Item # 8106HZ, Case UDI: 30889483166745) UDI-DI: 10889483166758 (Item # 8107HZ, Case UDI: 30889483166752) UDI-DI: 10889483166772 (Item # 8109HZ, Case UDI: 30889483166776) UDI-DI: 10889483166819 (Item # 8113HZ, Case UDI: 30889483166813) UDI-DI: 10889483169117 (Item # 8115HZ, Case UDI: 30889483169111) UDI-DI: 10889483167908 (Item # 8116HZ, Case UDI: 30889483167902) UDI-DI: 10889483171196 (Item # 8119HZ, Case UDI: 30889483171190) UDI-DI: 10889483166291 (Item # 9002HZ, Case UDI: 30889483166295) UDI-DI: 10889483166338 (Item # 9006HZ, Case UDI: 30889483166332) UDI-DI: 10889483165638 (Item # 9100HZ, Case UDI: 30889483165632) UDI-DI: 10889483165676 (Item # 9105HZ, Case UDI: 30889483165670) UDI-DI: 10889483165683 (Item # 9106HZ, Case UDI: 30889483165687) UDI-DI: 10889483165706 (Item # 9108HZ, Case UDI: 30889483165700) UDI-DI: 10889483165720 (Item # 9110HZ, Case UDI: 30889483165724) UDI-DI: 10889483165737 (Item # 9111HZ, Case UDI: 30889483165731) UDI-DI: 10889483171202 (Item # 9120HZ, Case UDI: 30889483171206) UDI-DI: 10889483230688 (Item # 9122HZ, Case UDI: 30889483230682) UDI-DI: 10889483167199 (Item # HZI600, Case UDI: 30889483167193) UDI-DI:10889483167307 (Item # HZI8100, Case UDI: 30889483167308) UDI-DI: 10889483167236 (Item # HZI9000, Case UDI: 30889483167230) UDI-DI: 10889483167793 (Item # HZI9108, Case UDI: 30889483167787) All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

Distribution pattern

US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.

device · product 4 of 9

Ventlab, LLC RescuMed manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. RescuMed Adult Resuscitator REF #s: BVM510-F, BVMB510-10, BVMB510-F, BVMB510S-F; 2. RescuMed Infant Resuscitator REF #s: BVMB710 & BVMB710-F; 3. RescuMed Pediatric Resuscitator REF #s: BVMB812, BVMB812-F, BVMB810, BVMB810-F, BVMB810S-F.

Z-0364-2024

Recall number: Z-0364-2024
Initiated: October 11, 2023
Classification: Class II
Status: Ongoing
Recalling firm: SunMed Holdings, LLC
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

Code information

UDI-DI: 10889483164266, (ITEM # BVM510-F, Case UDI: 30889483184680); UDI-D: 10889483164754, (ITEM # BVMB710, Case UDI: 30889483164758); UDI-DI: 10889483164785, (ITEM # BVMB812, Case UDI: 30889483164789); UDI-DI: 10889483164761, (ITEM # BVMB812-F, Case UDI: 30889483164765); UDI-DI: 10889483169605, (ITEM # BVMB510-10, Case UDI: 30889483169609); UDI-DI: 10889483164686, (ITEM # BVMB510-F, Case UDI: 0889483164680); UDI-DI: 10889483164693, (ITEM # BVMB510S-F, Case UDI: 3088948316469); UDI-DI: 10889483164747, (ITEM # BVMB710-F, Case UDI: 30889483164741); UDI-DI: 10889483164730, (ITEM # BVMB810, Case UDI: 30889483164734); UDI-DI: 10889483164716, (ITEM # BVMB810-F, Case UDI: 30889483164710); UDI-DI: 10889483164723, (ITEM # BVMB810S-F, Case UDI: 30889483164727). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

Distribution pattern

US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.

device · product 5 of 9

Ventlab, LLC SafeSpot manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. SafeSpot Infant Resuscitator REF #s: SS3200OBPC-T, SS3204MB-D12, SS3200MB-2, SS3200MB-D1, SS3200OBP, SS3200MB-MMC, SS3200MBP-M00, SS3200MB-PW, SS3200MBP-2I, SS3200MBF-2, SS3204MBF-2, SS3200MB- PWS10, SS3206MCP-S1, SS3204MB, SS3204MC-P2, SS3200MB, SS3200MBP-2, SS3200MBF, SS3200MB-I, SS3200MBP, SS3200OB, SS3200MC, SS3200MC-P2; 2. SafeSpot Safe Spot Bag, D1 Mask with Inflation Bag Reservoir, Manometer, PEEP Valve, and 40cm Pop-Off REF # PRO-1927.

Z-0365-2024

Recall number: Z-0365-2024
Initiated: October 11, 2023
Classification: Class II
Status: Ongoing
Recalling firm: SunMed Holdings, LLC
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

Code information

UDI-DI: 10889483104107, (Case UDI: 30889483104105, Item # PRO-1927); UDI-DI: 10889483102954, (Case UDI: 30889483102958, Item # SS3200MB); UDI-DI: 10889483092590, (Case UDI: 30889483092594, Item # SS3200MB-2); UDI-DI: 10889483104330, (Case UDI: 30889483104334, Item #SS3200MB-D1); UDI-DI: 10889483172322, (Case UDI: 30889483172326, Item # SS3200MBF); UDI-DI: 10889483104354, (Case UDI: 30889483104358, Item # SS3200MBF-2); UDI-DI: 10889483104545, (Case UDI: 30889483104549, Item # SS3200MB-I); UDI-DI: 10889483105771, (Case UDI: 30889483105775, Item # SS3200MB-MMC); UDI-DI: 10889483086919, (Case UDI: 30889483086913, Item # SS3200MBP); UDI-DI: 10889483104903, (Case UDI: 30889483104907, Item # SS3200MBP-2); UDI-DI: 10889483107324, (Case UDI: 30889483107328, Item # SS3200MBP-2I); UDI-DI: 10889483103777, (Case UDI: 30889483103771, Item # SS3200MBP-M00); UDI-DI: 10889483103111, (Case UDI: 30889483103115, Item # SS3200MB-PW); UDI-DI: 10889483086902, (Case UDI: 30889483086906, Item # SS3200MB- PWS10); UDI-DI: 10889483103784, (Case UDI: 30889483103788, Item # SS3200MC); UDI-DI: 10889483103128, (Case UDI: 30889483103122, Item # SS3200MC-P2); UDI-DI: 10889483107904, (Case UDI: 30889483107908, Item # SS3200OB); UDI-DI: 10889483086926, (Case UDI: 30889483086920, Item # SS3200OBP); UDI-DI: 10889483231142, (Case UDI: 30889483231146, Item # SS3200OBPC-T); UDI-DI: 10889483107331, (Case UDI: 30889483107335, Item # SS3204MB); UDI-DI: 10889483158913, (Case UDI: 30889483158917, Item # SS3204MB-D12); UDI-DI: 10889483104354, (Case UDI: 30889483104358, Item # SS3204MBF-2); UDI-DI: 10889483160497, (Case UDI: 30889483160491, Item # SS3204MC-P2); UDI-DI: 10889483111734, (Case UDI: 30889483111738, Item # SS3206MCP-S1. All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

Distribution pattern

US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.

device · product 6 of 9

Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult Resuscitator REF #: SC9101B; 2. STAT-Check Infant Resuscitator RES #s: SC7101B & SC7101B-M0; 3. STAT-Check Pediatric Resuscitator REF #: SC8121B.

Z-0366-2024

Recall number: Z-0366-2024
Initiated: October 11, 2023
Classification: Class II
Status: Ongoing
Recalling firm: SunMed Holdings, LLC
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

Code information

UDI-DI: 10889483109250, (Item # SC7101B, Case UDI: 30889483109254); UDI-DI: 10889483160671, (Item # SC7101B-M0. Case UDI: 30889483160675); UDI-DI: 10889483110041, (Item # SC8121B, Case UDI: 30889483110045); UDI-DI: 10889483098677, (Item # SC9101B , Case UDI: 30889483098671). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

Distribution pattern

US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.

device · product 7 of 9

Ventlab, LLC V-Care manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. V-Care Child Resuscitator REF #s: VN4100MB, VN4100MCFB-3, VN4100MCP; 2. V-Care Infant Resuscitator REF #s: VN3100OB, VN3100MB-2, VN3100MB-M01, VNW3100MB-2, VN3100MBP-3M, VN3100MB, VN3100MB-D1, VN3100MB-M00-0, VN3100MB-M1, VN3100OBP, VN3100MB-B, VN3100MB-I, VN3100MBP-000, VN3100MBP-2, VN3100MB-PW2, VN3100MBP, VN3100MBP-D1, VN3100MBPW-D2, VN3100MBP-F, VN3100MXK-2, VN3100MX-F, VN3100MC-2, VN3100MC, VN3100MC-B, VN3100MC-D1, VN3100MC-2U, VN3106MC-M1-2V, VN3104MCFB- M01, VN3106MC-D2V, VN3106MC-M1V, VN3100MCP-2, VN3100MCP, VN3106MCPF- M1V, VN3100MBF; 3. V-Care Pediatric Resuscitator REF #s: VN2100MB, VN2102MB, VN2102MBF, VN2102OBP, VN2100MBF, VN2100MBP, VN2100MB-PW, VN2102MX, VN2102MX-F, VN2100MX-M123, VN2100MC, VN2102MC, VN2102MC-B, VN2102MCP, VN2100MCP; 4. V-Care Small Adult Resuscitator REF #s: VN5000MB, VN5002MB, VN5100MB-F, VN5000MBPF, VN5000MBPF-I, VN5000MX, VN5100MX-F, VN5000MX-N, VN5000MXP, VN5000MXP-K, VN5000MC, VN5102MC, VN5100MCP, VN5000MC-N.

Z-0367-2024

Recall number: Z-0367-2024
Initiated: October 11, 2023
Classification: Class II
Status: Ongoing
Recalling firm: SunMed Holdings, LLC
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

Code information

ITEM # VN2100MB, UDI-DI: 10889483095379, (Case UDI: 30889483095373); ITEM # VN2100MBF, UDI-DI: 10889483092774, (Case UDI: 30889483092778); ITEM # VN2100MBP, UDI-DI: 10889483108260, (Case UDI: 30889483108264); ITEM # VN2100MB-PW, UDI-DI: 10889483108253, (Case UDI: 30889483108257); ITEM # VN2100MC, UDI-DI: 10889483108277, (Case UDI: 30889483108271); ITEM # VN2100MCP, UDI-DI: 10889483094525, (Case UDI: 30889483094529); ITEM # VN2100MX-M123, UDI-DI: 10889483098936, (Case UDI: 30889483098930); ITEM # VN2102MB, UDI-DI: 10889483105542, (Case UDI: 30889483105546); ITEM # VN2102MBF, UDI-DI: 10889483110966, (Case UDI: 30889483110960); ITEM # VN2102MC, UDI-DI: 10889483111994, (Case UDI: 30889483111998); ITEM # VN2102MC-B, UDI-DI: 10889483107393, (Case UDI: 30889483107397); ITEM # VN2102MCP, UDI-DI: 10889483088470, (Case UDI: 30889483088474); ITEM # VN2102MX, UDI-DI: 10889483095751, (Case UDI: 30889483095755); ITEM # VN2102MX-F, UDI-DI: 10889483105863, (Case UDI: 30889483105867); ITEM # VN2102OBP, UDI-DI: 10889483108895, (Case UDI: 30889483108899); ITEM # VN3100MB, UDI-DI: 10889483096994, (Case UDI: 30889483096998); ITEM # VN3100MB-2, UDI-DI: 10889483105900, (Case UDI: 30889483105904); ITEM # VN3100MB-B, UDI-DI: 10889483113585, (Case UDI: 30889483113589); ITEM # VN3100MB-D1, UDI-DI: 10889483105566, (Case UDI: 30889483105560); ITEM # VN3100MBF, UDI-DI: 10889483100622, (Case UDI: 30889483100626); ITEM # VN3100MB-I, UDI-DI: 10889483109380, (Case UDI: 30889483109384); ITEM # VN3100MB-M00- 0, UDI-DI: 10889483095980, (Case UDI: 30889483095984); ITEM # VN3100MB-M01, UDI-DI: 10889483110386, (Case UDI: 30889483110380); ITEM # VN3100MB-M1, UDI-DI: 10889483102763, (Case UDI: 30889483102767); ITEM # VN3100MBP, UDI-DI: 10889483100622, (Case UDI: 30889483100626); ITEM # VN3100MBP-000, UDI-DI: 10889483110393, (Case UDI: 30889483110397); ITEM # VN3100MBP-2, UDI-DI: 10889483104262, (Case UDI: 30889483104266); ITEM # VN3100MBP-3M, UDI-DI: 10889483100639, (Case UDI: 30889483100633); ITEM # VN3100MBP-D1, UDI-DI: 10889483110751, (Case UDI: 30889483110755); ITEM # VN3100MBP-F, UDI-DI: 10889483102770, (Case UDI: 30889483102774); ITEM # VN3100MB-PW2, UDI-DI: 10889483110744, (Case UDI: 30889483110748); ITEM # VN3100MBPW-D2, UDI-DI: 10889483111192, (Case UDI: 30889483111196); ITEM # VN3100MC, UDI-DI: 10889483100646, (Case UDI: 30889483100640); ITEM # VN3100MC-2, UDI-DI: 10889483111208, (Case UDI: 30889483111202); ITEM # VN3100MC-2U, UDI-DI: 10889483112113, (Case UDI: 30889483112117); ITEM # VN3100MC-B, UDI-DI: 10889483095768, (Case UDI: 30889483095762); ITEM # VN3100MC-D1, UDI-DI: 10889483112021, (Case UDI: 30889483112025); ITEM # VN3100MCP, UDI-DI: 10889483110768, (Case UDI: 30889483110762); ITEM # VN3100MCP-2, UDI-DI: 10889483113622, (Case UDI: 30889483113626); ITEM # VN3100MX-F, UDI-DI: 10889483112038, (Case UDI: 30889483112032); ITEM # VN3100MXK-2, UDI-DI: 10889483111215, (Case UDI: 30889483111219); ITEM # VN3100OB, UDI-DI: 10889483099964, (Case UDI: 30889483099968); ITEM # VN3100OBP, UDI-DI: 10889483105924, (Case UDI: 30889483105928); ITEM # VN3104MCFB- M01, UDI-DI: 10889483110775, (Case UDI: 30889483110779); ITEM # VN3106MC-D2V, UDI-DI: 10889483107539, (Case UDI: 30889483107533); ITEM # VN3106MC-M1- 2V, UDI-DI: 10889483095997, (Case UDI: 30889483095991); ITEM # VN3106MC-M1V, UDI-DI: 10889483097991, (Case UDI: 30889483097995); ITEM # VN3106MCPF- M1V, UDI-DI: 10889483099001, (Case UDI: 30889483099005); ITEM # VN4100MB, UDI-DI: 10889483111338, (Case UDI: 30889483111332); ITEM # VN4100MCFB-3, UDI-DI: 10889483111239, (Case UDI: 30889483111233); ITEM # VN4100MCP, UDI-DI: 10889483098042, (Case UDI: 30889483098046); ITEM # VN5000MB, UDI-DI: 10889483112052, (Case UDI: 30889483112056); ITEM # VN5000MBPF, UDI-DI: 10889483112229, (Case UDI: 30889483112223); ITEM # VN5000MBPF-I, UDI-DI: 10889483113646, (Case UDI: 30889483113640); ITEM # VN5000MC, UDI-DI: 10889483095393, (Case UDI: 30889483095397); ITEM # VN5000MC-N, UDI-DI: 10889483108352, (Case UDI: 30889483108356); ITEM # VN5000MX, UDI-DI: 10889483107782, (Case UDI: 30889483107786); ITEM # VN5000MX-N, UDI-DI: 10889483107553, (Case UDI: 30889483107557); ITEM # VN5000MXP, UDI-DI: 10889483089828, (Case UDI: 30889483089822); ITEM # VN5000MXP-K, UDI-DI: 10889483110409, (Case UDI: 30889483110403); ITEM # VN5002MB, UDI-DI: 10889483100660, (Case UDI: 30889483100664); ITEM # VN5100MB-F, UDI-DI: 10889483107560, (Case UDI: 30889483107564); ITEM # VN5100MCP, UDI-DI: 10889483098554, (Case UDI: 30889483098558); ITEM # VN5100MX-F, UDI-DI: 10889483095782, (Case UDI: 30889483095786); ITEM # VN5102MC, UDI-DI: 10889483109403, (Case UDI: 30889483109407); ITEM # VNW3100MB-2, UDI-DI: 10889483100677, (Case UDI: 30889483100671). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

Distribution pattern

US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.

device · product 8 of 9

Curaplex manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Curaplex Adult Premium BVM with Bag Reservoir, Manometer, Filter, Peep Valve & Mask, REF # 2442-BVMPAD; 2. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & Mask, REF # 2442-BVMPCH; 3. Curaplex Child Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, Infant and Neonate Mask, REF # 2442-BVMCIN; 4. Curaplex Infant Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter & 2 Masks, REF # 2442-BVMPIN; 5. Curaplex Small Adult Pediatric Premium BVM with Bag Reservoir, Manometer, 25cm Pop-off, Filter, PEEP Valve and 2 Masks, REF # 2442-BVMPSA.

Z-0368-2024

Recall number: Z-0368-2024
Initiated: October 11, 2023
Classification: Class II
Status: Ongoing
Recalling firm: SunMed Holdings, LLC
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

Code information

UDI-DI: 00810071633126, Item # 2442-BVMCIN; UDI-DI: 00812277037050, Item # 2442-BVMPAD; UDI-DI: 00812277037074, Item # 2442-BVMPCH; UDI-DI: 00812277037081, Item # 2442-BVMPIN; UDI-DI: 00812277037067, Item # 2442-BVMPSA. All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

Distribution pattern

US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.

device · product 9 of 9

Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s: CPRM1116FPM, CPRM1116FPM4, CPRM1116M, CPRM1116MC, CPRM1116PM, CPRM1116PMT, CPRM1126FM, CPRM1126FPM, CPRM1126FPWM, CPRM1126M; 2. Infant Resuscitator REF #s: CPRM3312FM, CPRM3312FM123, CPRM3312FPM, CPRM3312FPM3, CPRM3312FPMC, CPRM3312M, CPRM3312M3, CPRM3312P3M3, CPRM3312PM, CPRM3312PM2, CPRM3312PMC2, CPRM3312PMTD1, CPRM3312PMX, CPRM3312PWM, CPRM3322FM, CPRM3322M, CPRM3322PM; 3. Pediatric Resuscitator REF #s: CPRM2216FM, CPRM2216FM3, CPRM2216FPM, CPRM2216FPM3, CPRM2216FPMC, CPRM2216M, CPRM2216P3M3, CPRM2216PCM, CPRM2216PM, CPRM2216PM6, CPRM2226FM, CPRM2226FM3, CPRM2226FPM, CPRM2226FPWM, CPRM2226M; 4. Small Adult Resuscitator REF #s: CPRM4416FPMC, CPRM4416M, CPRM4426M.

Z-0369-2024

Recall number: Z-0369-2024
Initiated: October 11, 2023
Classification: Class II
Status: Ongoing
Recalling firm: SunMed Holdings, LLC
Quantity: N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.

Code information

UDI-DI:10888277628298, (Case UDI: 20888277698885, ITEM # CPRM1116FM); UDI-DI:10888277667785, (Case UDI: 20888277667782, ITEM # CPRM1116FMT); UDI-DI:10888277654815, (Case UDI: 20888277654812, ITEM # CPRM1116FPM); UDI-DI:10193489082685, (Case UDI: 20193489021544, ITEM # CPRM1116FPM4); UDI-DI:10888277628304, (Case UDI: 20888277628301, ITEM # CPRM1116M); UDI-DI:10888277698826, (Case UDI: 20888277698823, ITEM # CPRM1116MC); UDI-DI:10888277628311, (Case UDI: 20888277628318, ITEM # CPRM1116PM); UDI-DI:10888277674004, (Case UDI: 20888277674001, ITEM # CPRM1116PMT); UDI-DI:10888277629677, (Case UDI: 20888277629674, ITEM # CPRM1126FM); UDI-DI:10884389810293, (Case UDI: 20884389810290, ITEM # CPRM1126FPM); UDI-DI:10193489001945, (Case UDI: 20193489001942, ITEM # CPRM1126FPWM); UDI-DI:10888277628328, (Case UDI: 20888277628325, ITEM # CPRM1126M); UDI-DI:10888277655140, (Case UDI: 20888277655147, ITEM # CPRM2216FM); UDI-DI:10888277698857, (Case UDI: 20888277717678, ITEM # CPRM2216FM3); UDI-DI:10888277632332, (Case UDI: 20888277632339, ITEM # CPRM2216FPM); UDI-DI:10193489001150, (Case UDI: 20193489001157, ITEM # CPRM2216FPM3); UDI-DI:10193489181937, (Case UDI: 20193489181934, ITEM # CPRM2216FPMC); UDI-DI:10888277632349, (Case UDI: 20888277632346, ITEM # CPRM2216M); UDI-DI:10193489009750, (Case UDI: 20193489009757, ITEM # CPRM2216P3M3); UDI-DI:10888277669833, (Case UDI: 20888277669830, ITEM # CPRM2216PCM); UDI-DI:10888277629684, (Case UDI: 20888277629681, ITEM # CPRM2216PM); UDI-DI:10193489016000, (Case UDI: 40884389121260, ITEM # CPRM2216PM6); UDI-DI:10888277655157, (Case UDI: 20888277655154, ITEM # CPRM2226FM); UDI-DI:10888277659766, (Case UDI: 20888277659763, ITEM # CPRM2226FM3); UDI-DI:10884389811337, (Case UDI: 20884389811334, ITEM # CPRM2226FPM); UDI-DI:10193489001952, (Case UDI: 20193489001959, ITEM # CPRM2226FPWM); UDI-DI:10888277632356, (Case UDI: 20888277632353, ITEM # CPRM2226M); UDI-DI:10888277656130, (Case UDI: 20888277656137, ITEM # CPRM3312FM); UDI-DI:10888277698871, (Case UDI: 20888277698878, ITEM # CPRM3312FM123); UDI-DI:10888277654822, (Case UDI: 20888277654829, ITEM # CPRM3312FPM); UDI-DI:10193489001167, (Case UDI: 20193489001164, ITEM # CPRM3312FPM3); UDI-DI:10193489181944, (Case UDI: 20193489181941, ITEM # CPRM3312FPMC); UDI-DI:10888277632363, (Case UDI: 20888277632360, ITEM # CPRM3312M); UDI-DI:10888277698888, (Case UDI: 40888277362605, ITEM # CPRM3312M3); UDI-DI:10193489009767, (Case UDI: 20193489009764, ITEM # CPRM3312P3M3); UDI-DI:10888277718652, (Case UDI: 20888277718569, ITEM # CPRM3312PM); UDI-DI:10884389975893, (Case UDI: 20884389975890, ITEM # CPRM3312PM2); UDI-DI:10888277675193, (Case UDI: 20888277675190, ITEM # CPRM3312PMC2); UDI-DI:10888277674028, (Case UDI: 20888277674025, ITEM # CPRM3312PMTD1); UDI-DI:10884389975909, (Case UDI: 20884389975906, ITEM # CPRM3312PMX); UDI-DI:10888277667815 (Case UDI: 20888277667812, ITEM # CPRM3312PWM); UDI-DI:10080196659777, (Case UDI: 20080196659774, ITEM # CPRM3322FM); UDI-DI:10888277632370, (Case UDI: 20888277632377, ITEM # CPRM3322M); UDI-DI:10888277718562, (Case UDI: 20888277718569, ITEM # CPRM3322PM); UDI-DI:10193489181951, (Case UDI: 20193489181958, ITEM # CPRM4416FPMC); UDI-DI:10888277700499, (Case UDI: 20888277700496, ITEM # CPRM4416M); UDI-DI:10888277700512, (Case UDI: 20888277700519, ITEM # CPRM4426M). All lots manufactured from 9/21/2018 to present. Latest expiration Date 10/11/2028.

Distribution pattern

US Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MN, NC, ND, NH, NJ, NM, NV, NY, OH, SC, TN, TX, UT, VA, & WV.

Event 93237

Event summary

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Every recalled product in this event

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Ventlab, LLC STAT-Check manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. STAT-Check Adult Resuscitator REF #: SC9101B; 2. STAT-Check Infant Resuscitator RES #s: SC7101B & SC7101B-M0; 3. STAT-Check Pediatric Resuscitator REF #: SC8121B.

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