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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83461

8 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 30, 2019
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Teleflex Medical

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

8 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 8

Hudson RCI Sheridan LTS: a) 4.0 mm, REF 5-11108 b) 5.0 mm, REF 5-11110 c) 6.0 mm, REF 5-11112 Product Usage: Tracheal tube/airway management

Z-2311-2019
Recall number
Z-2311-2019
Initiated
July 30, 2019
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
7963 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Code information

a) REF 5-11108 Batch numbers: 73L1600010 73A1700644 73C1700236 73D1700438 73E1700473 73F1700385 73K1700066 73L1700501 73B1800123 73D1800137 73F1800172 73G1800124 73G1800925 73H1800731 b) REF 5-11110 Batch numbers: 73K1600368 73K1600727 73A1700645 73B1700410 73C1700237 73D1700624 73E1700474 73F1700386 73H1700040 73H1700482 73H1700599 73J1700291 73K1700067 73L1700502 73M1700452 73B1800124 73D1800313 73F1800173 73G1800125 73K1800170 73L1800224 c) REF 5-11112 Batch numbers: 73K1600369 73L1600011 73A1700646 73C1700238 73D1700625 73E1700475 73F1700387 73H1700041 73H1700483 73J1700292 73L1700503 73M1700453 73A1800671 73B1800350 73D1800138 73F1800174 73G1800126 73G1800806 73J1800308 73K1800173 73L1800225 73K1800172

Distribution pattern

US Nationwide Distribution

device · product 2 of 8

Hudson RCI Sheridan/CF: a) 3.0 mm, REF 5-10106, REF 5-10206 b) 3.5 mm, REF 5-10107 c) 4.0 mm, REF 5-10108, REF 5-10208 d) 4.5 mm, REF 5-10109 e) 5.0 mm, REF 5-10110, REF 5-10210 f) 5.5 mm, REF 5-10111 g) 6.0 mm, REF 5-10112, REF 5-10212 h) 6.5 mm, REF 5-10113, REF 5-10213 I) 7.0 mm, REF 5-10114, REF 5-10214 j) 7.5 mm, REF V5-10115, REF 5-10115, REF 5-10215 k) 8.0 mm, REF 5-10116, REF 5-10216, REF V5-10116 l) 8.5 mm, REF 5-10117, REF 5-10217 m) 9.0 mm, REF 5-10118, REF5-10218 n) 9.5 mm, REF 5-10119 o) 10.0 mm, REF 5-10120, REF 5-10220 Product Usage: Tracheal tube/airway management

Z-2312-2019
Recall number
Z-2312-2019
Initiated
July 30, 2019
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
1805730 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Code information

a) REF 5-10106 Batch numbers: 73L1600638 73L1600825 73M1600121 73A1700079 73C1700394 73D1700234 73D1700235 73D1700436 73E1700214 73E1700450 73F1700366 73G1700211 73G1700579 73H1700309 73H1700461 73H1700583 73H1700768 73J1700119 73J1700585 73K1700245 73K1700718 73L1700302 73L1700654 73M1700232 73A1800276 73A1800428 73B1800112 73B1800472 73B1800614 73C1800332 73D1800120 73D1800446 73E1800373 73E1800775 73G1800111 73H1800174 73H1800711 73J1800313 73J1800492 73K1800151 73K1800320 73K1800356 73K1800708 73L1800210 73L1800386 73M1800158 REF 5-10206 Batch numbers: 73H1700470 73J1700455 73L1700647 73B1800338 73F1800704 73K1800012 73K1800364 b) REF 5-10107 Batch numbers: 73K1600124 73K1600348 73K1600560 73K1600718 73L1600480 73L1600639 73L1600826 73A1700080 73A1700241 73C1700395 73C1700538 73C1700670 73D1700404 73E1700215 73E1700451 73F1700139 73F1700367 73F1700695 73G1700212 73G1700400 73G1700580 73H1700029 73H1700462 73H1700584 73H1700769 73J1700120 73J1700273 73J1700586 73K1700246 73K1700399 73K1700706 73K1700719 73L1700303 73L1700497 73L1700655 73M1700233 73M1700417 73A1800277 73A1800436 73A1800804 73B1800473 73B1800696 73C1800333 73C1800449 73C1800465 73D1800122 73D1800447 73D1800619 73D1800679 73E1800542 73E1800543 73F1800154 73F1800525 73F1800694 73G1800208 73G1800559 73K1800532 73K1800743 73L1800211 73L1800512 c) REF 5-10108 Batch numbers: 73K1600719 73L1600128 73L1600321 73L1600481 73L1600827 73A1700081 73A1700242 73B1700285 73B1700612 73C1700221 73C1700539 73D1700119 73D1700606 73E1700216 73E1700452 73E1700694 73F1700006 73F1700140 73F1700368 73F1700529 73G1700133 73G1700401 73G1700581 73H1700030 73H1700310 73H1700463 73H1700585 73H1700770 73J1700121 73J1700274 73J1700587 73K1700049 73K1700247 73K1700400 73L1700161 73L1700519 73M1700129 73M1700234 73M1700418 73M1700443 73A1800278 73A1800654 73B1800113 73B1800697 73C1800176 73C1800466 73D1800123 73D1800296 73D1800620 73D1800621 73E1800067 73E1800374 73E1800700 73F1800155 73F1800321 73F1800526 73G1800112 73G1800209 73G1800789 73H1800175 REF 5-10208 Batch numbers: 73L1600485 73J1700456 73K1700408 73C1800474 73H1800656 73K1800365 d) REF 5-10109 Batch numbers: 73L1600129 73L1600130 73L1600322 73L1600644 73M1600123 73A1700082 73A1700243 73B1700286 73C1700222 73C1700540 73C1700671 73D1700607 73E1700087 73E1700453 73E1700695 73F1700007 73F1700141 73F1700530 73F1700696 73G1700134 73G1700402 73G1700582 73H1700031 73H1700311 73H1700586 73H1700771 73J1700122 73J1700275 73K1700050 73K1700579 73L1700293 73L1700520 73L1700656 73M1700130 73M1700235 73M1700419 73A1800041 73A1800655 73A1800805 73B1800332 73C1800180 73C1800557 73D1800297 73E1800068 73E1800224 73E1800776 73F1800322 73F1800695 73G1800790 73G1800906 73H1800415 73J1800314 73J1800494 73J1800655 73K1800753 73L1800591 e) REF 5-10110 Batch numbers: 73J1600742 73K1600128 73K1600351 73K1600563 73L1600006 73L1600131 73L1600323 73L1600640 73L1600828 73A1700244 73B1700287 73B1700393 73B1700613 73D1700120 73D1700608 73E1700241 73E1700696 73F1700142 73F1700531 73G1700135 73G1700583 73H1700032 73H1700464 73H1700587 73H1700772 73J1700123 73J1700276 73J1700448 73J1700614 73K1700051 73K1700248 73K1700401 73K1700580 73L1700164 73L1700304 73L1700657 73M1700131 73M1700420 73A1800279 73A1800437 73A1800661 73A1800806 73B1800333 73B1800698 73C1800181 73C1800334 73C1800467 73C1800558 73D1800124 73D1800298 73D1800622 73E1800245 73E1800375 73E1800777 73F1800527 73F1800696 73G1800113 73G1800560 73G1800907 73H1800176 73H1800210 73K1800358 73K1800534 73K1800710 73L1800514 REF 5-10210 Batch numbers: 73J1700457 73L1700648 73K1800366 f) REF 5-10111 Batch numbers: 73J1600351 73J1600720 73K1600129 73K1600564 73L1600007 73L1600324 73L1600641 73L1600829 73M1600125 73A1700084 73A1700245 73B1700614 73C1700396 73D1700121 73D1700609 73E1700697 73G1700136 73G1700213 73G1700584 73H1700465 73H1700588 73H1700773 73J1700124 73J1700449 73K1700052 73K1700172 73K1700581 73L1700165 73L1700305 73L1700658 73M1700132 73M1700335 73M1700444 73A1800280 73A1800438 73A1800807 73B1800334 73B1800699 73C1800182 73C1800335 73C1800468 73D1800125 73D1800299 73D1800623 73E1800778 73F1800156 73F1800323 73F1800528 73G1800114 73G1800211 73G1800561 73H1800177 73K1800379 73L1800537 g) REF 5-10112 Batch numbers: 73J1600560 73J1600743 73K1600130 73K1600565 73L1600008 73L1600325 73L1600642 73L1600830 73M1600126 73A1700085 73A1700246 73A1700717 73B1700288 73B1700395 73B1700615 73C1700223 73C1700397 73C1700541 73D1700236 73D1700610 73E1700217 73E1700454 73E1700698 73F1700532 73G1700137 73G1700214 73G1700585 73H1700033 73H1700466 73J1700125 73J1700277 73J1700588 73K1700053 73K1700249 73K1700394 73K1700582 73L1700166 73L1700306 73L1700521 73L1700659 73M1700133 73M1700445 73A1800042 73A1800281 73A1800662 73B1800114 73B1800474 73B1800700 73C1800183 73C1800469 73D1800300 73D1800624 73E1800061 73E1800225 73E1800779 73F1800157 73F1800529 73F1800697 73G1800115 73G1800212 73G1800562 73G1800791 73H1800178 73H1800652 73J1800082 73J1800317 73J1800496 73J1800656 73K1800359 73L1800193 REF 5-10212 Batch numbers: 73J1600560 73J1600743 73K1600130 73K1600565 73L1600008 73L1600325 73L1600642 73L1600830 73M1600126 73A1700085 73A1700246 73A1700717 73B1700288 73B1700395 73B1700615 73C1700223 73C1700397 73C1700541 73D1700236 73D1700610 73E1700217 73E1700454 73E1700698 73F1700532 73G1700137 73G1700214 73G1700585 73H1700033 73H1700466 73J1700125 73J1700277 73J1700588 73K1700053 73K1700249 73K1700394 73K1700582 73L1700166 73L1700306 73L1700521 73L1700659 73M1700133 73M1700445 73A1800042 73A1800281 73A1800662 73B1800114 73B1800474 73B1800700 73C1800183 73C1800469 73D1800300 73D1800624 73E1800061 73E1800225 73E1800779 73F1800157 73F1800529 73F1800697 73G1800115 73G1800212 73G1800562 73G1800791 73H1800178 73H1800652 73J1800082 73J1800317 73J1800496 73J1800656 73K1800359 73L1800193 h) REF 5-10113 Batch numbers: 73J1600561 73J1600744 73K1600131 73K1600352 73K1600566 73K1600567 73L1600132 73L1600326 73L1600482 73L1600831 73M1600127 73A1700086 73A1700247 73A1700400 73A1700640 73A1700718 73B1700289 73B1700396 73B1700616 73C1700542 73C1700672 73D1700122 73D1700237 73D1700405 73E1700455 73E1700699 73F1700533 73F1700697 73G1700215 73G1700403 73H1700312 73H1700589 73H1700775 73J1700126 73J1700278 73J1700450 73J1700589 73K1700250 73K1700402 73K1700583 73L1700167 73L1700307 73L1700522 73L1700660 73M1700134 73M1700446 73A1800038 73A1800663 73B1800115 73B1800475 73B1800701 73C1800184 73C1800336 73C1800559 73D1800060 73D1800301 73D1800625 73E1800069 73E1800226 73E1800376 73E1800780 73F1800158 73F1800324 73F1800530 73F1800698 73G1800213 73H1800179 73J1800318 73K1800360 REF 5-10213 Batch numbers: 73A1700252 73D1700241 73J1700458 73B1800339 I) REF 5-10114 Batch numbers: 73J1600745 73J1600746 73J1600747 73K1600132 73K1600720 73L1600327 73L1600328 73L1600832 73L1600833 73M1600272 73A1700087 73A1700088 73B1700290 73B1700291 73B1700292 73B1700293 73B1700397 73C1700398 73C1700399 73C1700400 73C1700543 73C1700544 73C1700545 73C1700546 73D1700611 73E1700088 73E1700089 73E1700090 73E1700700 73F1700143 73F1700138 73F1700534 73F1700535 73F1700698 73G1700144 73G1700145 73G1700216 73G1700586 73G1700587 73H1700034 73H1700467 73H1700590 73J1700149 73J1700150 73J1700279 73J1700590 73K1700054 73K1700055 73K1700056 73K1700251 73K1700584 73K1700720 73M1700236 73M1700237 73M1700427 73M1700428 73A1800439 73A1800440 73A1800441 73B1800220 73B1800221 73B1800222 73B1800219 73B1800335 73B1800336 73C1800337 73C1800338 73C1800339 73C1800470 73C1800471 73C1800472 73C1800473 73D1800448 73D1800449 73D1800450 73D1800626 73D1800627 73E1800544 73E1800545 73E1800781 73F1800112 73F1800531 73F1800532 73F1800699 73F1800700 73F1800701 73G1800116 73G1800117 73G1800214 73H1800180 73H1800715 73J1800084 73J1800498 73J1800499 73J1800657 73L1800511 73K1800714 73K1800715 REF 5-10214 Batch numbers: 73K1600136 73K1600722 73L1600334 73L1600405 73M1600269 73C1700401 73D1700614 73F1700144 73G1700124 73H1700036 73M1700204 73M1700429 73A1800297 73B1800340 73C1800343 73D1800628 73E1800547 73F1800705 73H1800720 73J1800086 73J1800660 j) REF V5-10115 Batch numbers: 73J1600386 73L1600171 73L1600517 73M1600276 73B1700164 73C1700701 73D1700264 73E1700505 73G1700435 73H1700054 73H1700795 73K1700280 73K1700752 73B1800511 73D1800157 73E1800097 73E1800234 73F1800361 73G1800594 73H1800204 73H1800687 73J1800119 73K1800323 REF 5-10115 Batch numbers: 73J1600562 73K1600133 73K1600134 73L1600133 73L1600483 73L1600645 73M1600128 73A1700248 73A1700719 73A1700720 73B1700131 73B1700132 73B1700626 73B1700627 73C1700224 73C1700225 73C1700226 73C1700673 73C1700674 73D1700123 73D1700124 73D1700238 73E1700218 73E1700219 73E1700220 73E1700456 73F1700369 73F1700370 73F1700371 73G1700217 73G1700404 73H1700035 73H1700313 73H1700591 73H1700776 73J1700280 73J1700451 73K1700252 73K1700253 73K1700403 73K1700404 73K1700721 73L1700191 73L1700308 73L1700309 73M1700447 73M1700448 73A1800656 73A1800796 73A1800797 73B1800476 73B1800477 73B1800478 73C1800561 73D1800126 73D1800127 73D1800128 73D1800287 73E1800063 73E1800070 73E1800222 73E1800366 73E1800367 73F1800159 73F1800160 73F1800302 73F1800325 73F1800326 73F1800533 73F1800534 73G1800563 73G1800795 73G1800796 73G1800794 73H1800074 73H1800181 73H1800653 73H1800716 73J1800085 73J1800328 73J1800500 73K1800324 73K1800361 73K1800362 73K1800535 73K1800536 73L1800263 REF 5-10215 Batch numbers: 73M1600131 73H1700316 73L1700310 73M1700436 73B1800452 73E1800368 73F1800327 73G1800555 73H1800182 73H1800721 73J1800087 73K1800368 k) REF 5-10116 Batch numbers: 73J1600563 73J1600678 73J1600748 73K1600569 73L1600134 73L1600329 73L1600330 73L1600404 73L1600646 73L1600834 73M1600129 73A1700650 73B1700398 73B1700628 73D1700239 73D1700412 73D1700413 73D1700414 73D1700612 73F1700009 73F1700010 73F1700699 73F1700700 73G1700405 73G1700588 73H1700314 73H1700468 73J1700145 73J1700452 73J1700591 73K1700395 73K1700585 73M1700026 73M1700135 73M1700136 73A1800048 73A1800049 73A1800050 73A1800387 73B1800709 73B1800710 73C1800185 73D1800289 73D1800451 73E1800782 73F1800019 73F1800018 73G1800215 73G1800565 73G1800564 73H1800432 73H1800433 73H1800692 73J1800329 73J1800501 73J1800650 73K1800158 73K1800159 73K1800228 REF 5-10216 Batch numbers: 73J1600750 73L1600335 73L1600648 73B1700401 73D1700242 73F1700012 73F1700701 73G1700409 73H1700317 73J1700147 73J1700592 73A1800052 73B1800712 73G1800217 73J1800331 73J1800661 73K1800162 REF V5-10116 Batch numbers: 73J1600771 73L1600172 73L1600671 73B1700427 73D1700265 73F1700037 73F1700733 73G1700436 73H1700351 73J1700146 73J1700608 73K1700088 73M1700027 73A1800248 73B1800692 73C1800204 73D1800482 73F1800020 73G1800233 73H1800455 73H1800689 73J1800330 73K1800194 l) REF 5-10117 Batch numbers: 73L1600331 73L1600647 73C1700675 73D1700613 73F1700528 73G1700406 73H1700315 73J1700281 73B1800711 73C1800562 73F1800161 73G1800910 73J1800008 73J1800502 73K1800537 REF 5-10217 Batch numbers: 73B1800713 73F1800162 73J1800506 73K1800538 m) REF 5-10118 Batch numbers: 73L1600009 73L1600332 73M1600130 73A1700089 73A1700249 73B1700399 73C1700547 73D1700406 73E1700701 73F1700536 73G1700407 73H1700592 73J1700282 73K1700405 73M1700137 73A1800039 73A1800808 73B1800337 73C1800340 73D1800130 73D1800302 73E1800783 73F1800535 73G1800798 73H1800654 73J1800319 73J1800503 73J1800658 73K1800363 73K1800755 73L1800217 73L1800596 REF5-10218 Batch numbers: 73C1700549 73J1800347 73J1800715 n) REF 5-10119 Batch numbers: 73L1600484 73L1600835 73A1700090 73A1700250 73D1700407 73F1700372 73F1700537 73G1700408 73H1700469 73J1700453 73M1700449 73A1800040 73B1800116 73B1800601 73C1800341 73D1800121 73D1800452 73E1800546 73F1800702 73H1800717 73K1800160 o) REF 5-10120 Batch numbers: 73B1700294 73D1700125 73D1700240 73G1700589 73H1700506 73H1700593 73M1700238 73A1800051 73B1800479 73C1800342 73D1800131 73D1800453 73E1800377 73F1800703 73G1800566 73H1800655 73J1800348 73K1800161 REF 5-10220 Batch numbers: 73C1800475 73J1800507

Distribution pattern

US Nationwide Distribution

device · product 3 of 8

Hudson RCI Sheridan EZ-ENDO: a) 5.0 mm, REF 5-22510 b) 5.5 mm, REF 5-22511 c) 7.0 mm, REF 5-22514 d) 7.5 mm, REF 5-22515 e) 8.0 mm, REF 5-22516 f) 8.5 mm, REF 5-22517 g) 9.0 mm, REF 5-22518 h) 6.0 mm, REF 5-22512 i) 6.5 mm, REF 5-22513 Product Usage: Tracheal tube/airway management

Z-2313-2019
Recall number
Z-2313-2019
Initiated
July 30, 2019
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
57181units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Code information

a) REF 5-22510 Batch numbers: 73B1700556 73D1700650 73H1700346 73H1800449 b) REF 5-22511 Batch numbers: 73C1700261 73K1700609 73C1800370 c) REF 5-22514 Batch numbers: 73A1700118 73C1700569 73E1700722 73F1700175 73F1700405 73G1700433 73H1700349 73H1700494 73H1700711 73J1700143 73K1700081 73K1700610 73L1700181 73M1700273 73D1800653 73F1800562 73F1800720 73H1800450 73J1800531 73K1800328 73K1800786 d) REF 5-22515 Batch numbers: 73B1700316 73C1700262 73C1700418 73E1700723 73E1700104 73F1700176 73F1700406 73G1700434 73H1700350 73J1700302 73J1700497 73K1700747 73M1700274 73A1800068 73A1800683 73B1800502 73C1800201 73D1800154 73E1800402 73F1800565 73G1800591 73H1800451 73H1800686 73J1800113 73K1800736 e) REF 5-22516 Batch numbers: 73K1600594 73A1700282 73B1700158 73B1700317 73C1700570 73F1700036 73F1700177 73F1700407 73G1700614 73H1700495 73J1700487 73K1700082 73A1800684 73B1800503 73C1800371 73E1800577 73G1800232 73J1800532 73K1800327 f) REF 5-22517 Batch numbers: 73J1600767 73C1800202 g) REF 5-22518 Batch numbers: 73K1600595 73E1800459 73M1800288 h) REF 5-22512 Batch numbers: 73K1600152 73M1600163 73A1700280 73C1700567 73E1700496 73F1700403 73H1700347 73M1700272 73E1800401 73E1800575 73F1800354 i) REF 5-22513 Batch numbers: 73J1600766 73B1700155 73C1700568 73F1700404 73G1700432 73H1700348 73E1800576 73F1800355

Distribution pattern

US Nationwide Distribution

device · product 4 of 8

Hudson RCI Sheridan Preformed: a) 3.0 mm, REF 5-22006, REF 5-22106 b) 3.5 mm, REF 5-22007, REF 5-22107 c) 4.0 mm, REF 5-22008, REF 5-22108, REF 5-22208 d) 4.5 mm, REF 5-22009, REF 5-22109, REF 5-22209 e) 5.0 mm, REF 5-22010, REF 5-22110, REF 5-22210 f) 5.5 mm, REF 5-22011, REF 5-22111, REF 5-22211 g) 6.0 mm, REF 5-22212, REF 5-22312, REF 5-22112 h) 6.5 mm, REF 5-22313, REF 5-22213, REF 5-22013, REF 5-22113 i) 7.0 mm, REF 5-22214, REF 5-22314, REF 5-22014, REF 5-22114 j) 7.5 mm, REF 5-22215, REF 5-22315 k) 8.0 mm, REF 5-22216, REF 5-22316 l) 8.5 mm, REF 5-22217 m) 9.0 mm, REF 5-22218 Product Usage: Tracheal tube/airway management

Z-2314-2019
Recall number
Z-2314-2019
Initiated
July 30, 2019
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
278142 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Code information

a) REF 5-22006 Batch numbers: 73E1700489 73G1700128 73K1700075 73L1700176 73C1800361 73E1800241 73F1800556 73G1800589 73G1800932 73L1800417 73L1800418 73M1800194 73M1800195 REF 5-22106 Batch numbers: 73E1700719 73M1700260 73E1800567 73J1800524 73K1800731 b) REF 5-22007 Batch numbers: 73L1600002 73K1700426 73A1800460 73D1800648 73E1800565 REF 5-22107 Batch numbers: 73L1600864 73F1700166 73E1800088 73K1800772 c) REF 5-22008 Batch numbers: 73C1700413 73F1700164 73G1700129 73J1700300 73A1800461 73B1800362 73F1800183 REF 5-22108 Batch numbers: 73K1600590 73M1600152 73A1700110 73D1700629 73F1700028 73B1800133 73E1800089 73G1800933 73J1800100 REF 5-22208 Batch numbers: 73L1600360 73A1700112 73D1700258 73F1700032 73F1700725 73G1700605 73H1700786 73J1700478 73K1700275 73K1700740 73L1700508 73M1700263 73A1800316 73A1800816 73B1800493 73C1800365 73D1800147 73E1800091 73E1800569 73F1800557 73H1800679 d) REF 5-22009 Batch numbers: 73L1600003 73C1700414 73D1700640 73F1700026 73G1700130 73H1700610 73K1700274 73A1800066 73C1800464 73D1800649 73E1800566 73F1800340 73L1800633 73L1800822 REF 5-22109 Batch numbers: 73L1600160 73L1600865 73M1600153 73A1700275 73B1700310 73C1700563 73D1700423 73F1700029 73H1700613 73J1700475 73K1700428 73M1700261 73B1800363 73C1800362 73D1800652 73E1800568 73G1800819 73H1800444 73J1800525 73K1800762 73L1800823 REF 5-22209 Batch numbers: 73L1600127 73L1600509 73M1600156 73A1700279 73B1700311 73D1700132 73D1700424 73E1700720 73F1700169 73G1700606 73H1700338 73J1700479 73K1700276 73K1700429 73L1700177 73L1700509 73M1700264 73A1800024 73A1800300 73B1800135 73B1800454 73C1800491 73D1800148 73E1800092 73E1800395 73F1800719 73H1800194 73J1800103 e) REF 5-22010 Batch numbers: 73A1700109 73B1700414 73D1700627 73H1700611 73A1800044 73C1800550 73E1800393 73G1800590 REF 5-22110 Batch numbers: 73K1600591 73L1600161 73L1600866 73A1700111 73A1700276 73B1700416 73C1700251 73C1700693 73F1700030 73G1700425 73J1700476 73L1700333 73M1700262 73B1800453 73C1800363 73E1800090 73F1800343 73G1800820 73H1800445 73K1800733 REF 5-22210 Batch numbers: 73K1600379 73L1600361 73L1600663 73M1600157 73B1700312 73C1700254 73D1700641 73F1700170 73F1700726 73G1700607 73H1700339 73H1700616 73J1700135 73J1700447 73K1700607 73L1700178 73L1700334 73M1700265 73A1800448 73B1800136 73B1800494 73C1800498 73E1800093 73F1800558 f) REF 5-22011 Batch numbers: 73K1600589 73L1600862 73B1700309 73D1700628 73F1700165 73L1700331 73A1800020 73D1800650 73F1800341 REF 5-22111 Batch numbers: 73J1600377 73K1600592 73L1600358 73L1600867 73M1600154 73A1700277 73B1700417 73C1700564 73F1700398 73H1700614 73J1700477 73A1800067 73B1800134 73C1800364 73F1800344 REF 5-22211 Batch numbers: 73K1600380 73K1600729 73L1600664 73B1700420 73C1700255 73D1700133 73D1700642 73F1700033 73F1700727 73G1700608 73H1700340 73H1700787 73J1700136 73J1700480 73K1700430 73K1700741 73L1700510 73M1700266 73A1800301 73A1800449 73B1800137 73B1800495 73C1800177 73D1800149 73E1800094 73F1800184 73F1800559 73L1800437 g) REF 5-22212 Batch numbers: 73J1600378 73K1600730 73L1600665 73M1600158 73B1700049 73B1700313 73C1700416 73D1700643 73F1700034 73F1700171 73F1700728 73G1700609 73H1700341 73J1700481 73J1700681 73K1700431 73L1700179 73L1700511 73M1700267 73A1800302 73A1800450 73B1800138 73C1800551 73D1800150 73E1800570 73F1800345 73H1800196 73J1800290 73K1800186 REF 5-22312 Batch numbers: 73K1600151 73L1600512 73M1600159 73A1700737 73B1700423 73C1700697 73D1700426 73E1700561 73E1700721 73F1700173 73F1700730 73G1700612 73H1700620 73J1700141 73J1700484 73K1700078 73K1700433 73K1700744 73L1700516 73A1800023 73B1800140 73B1800500 73C1800328 73D1800474 73E1800398 73F1800561 73G1800139 73H1800683 73J1800109 73K1800188 REF 5-22112 Batch numbers: 73L1600359 73M1600155 73A1700278 73C1700415 73F1700168 73G1700426 73H1700615 73L1700650 73B1800492 73H1800678 73K1800326 73K1800374 h) REF 5-22313 Batch numbers: 73J1600382 73K1600384 73K1600732 73L1600668 73M1600160 73A1700116 73A1700738 73C1700698 73D1700647 73E1700760 73F1700401 73G1700613 73H1700621 73J1700485 73K1700079 73K1700434 73K1700745 73M1700270 73A1800304 73B1800367 73C1800368 73D1800292 73E1800399 73F1800351 73G1800140 73G1800821 REF 5-22213 Batch numbers: 73K1600149 73L1600666 73A1700114 73B1700314 73C1700694 73D1700644 73F1700400 73G1700428 73H1700342 73H1700788 73J1700482 73K1700277 73L1700180 73L1700512 73M1700268 73A1800451 73B1800496 73D1800151 73E1800571 73F1800346 REF 5-22013 Batch numbers: 73A1700274 73H1700612 73J1700474 REF 5-22113 Batch numbers: 73G1700427 73E1800394 i) REF 5-22214 Batch numbers: 73J1600379 73K1600593 73L1600667 73B1700315 73C1700695 73D1700425 73E1700493 73G1700429 73H1700493 73J1700137 73K1700076 73K1700608 73L1700335 73M1700269 73M1700459 73A1800452 73B1800364 73B1800497 73C1800366 73D1800472 73E1800572 73F1800347 73G1800935 73H1800447 73H1800681 73J1800106 REF 5-22314 Batch numbers: 73J1600383 73L1600164 73L1600868 73M1600161 73A1700117 73A1700739 73C1700566 73D1700648 73F1700065 73F1700731 73G1700431 73H1700622 73J1700142 73K1700080 73K1700746 73M1700461 73A1800455 73B1800141 73B1800456 73D1800153 73D1800475 73E1800574 73F1800352 73G1800141 73G1800822 73J1800111 73K1800190 REF 5-22014 Batch numbers: 73F1700027 73K1700427 73F1800342 73K1800182 73K1800730 REF 5-22114 Batch numbers: 73F1700399 73K1800734 j) REF 5-22215 Batch numbers: 73J1600380 73K1600150 73C1700257 73C1700565 73D1700645 73E1700494 73F1700729 73G1700610 73H1700617 73J1700138 73J1700483 73K1700432 73K1700742 73L1700513 73M1700146 73A1800453 73B1800365 73B1800498 73C1800367 73D1800473 73E1800396 73F1800185 73F1800560 73J1800527 REF 5-22315 Batch numbers: 73J1600384 73L1600869 73M1600162 73C1700417 73D1700134 73D1700649 73F1700174 73F1700732 73H1700344 73H1700789 73J1700486 73K1700278 73M1700271 73A1800022 73A1800456 73B1800142 73C1800369 73D1800476 73E1800400 73G1800142 73G1800823 73H1800685 73J1800112 73J1800690 73K1800191 k) REF 5-22216 Batch numbers: 73J1600381 73K1600383 73L1600162 73L1600511 73A1700115 73A1700736 73B1700422 73C1700258 73C1700696 73D1700646 73E1700495 73F1700172 73F1700554 73G1700611 73H1700618 73J1700139 73K1700743 73L1700514 73M1700147 73M1700460 73A1800454 73B1800139 73B1800499 73D1800152 73E1800573 73F1800348 73G1800137 73H1800682 73J1800107 73J1800528 REF 5-22316 Batch numbers: 73C1700260 73C1700795 73F1700402 73H1700345 73H1700790 73L1700517 73B1800501 73D1800477 73F1800353 73G1800824 73H1800755 73K1800192 l) REF 5-22217 Batch numbers: 73L1600163 73L1600363 73C1700796 73F1700555 73H1700343 73J1700140 73L1700515 73M1700148 73A1800025 73A1800303 73B1800366 73B1800724 73E1800397 73F1800349 73J1800529 73L1800828 m) REF 5-22218 Batch numbers: 73F1700556 73G1700430 73H1700619 73J1700301 73F1800350 73G1800138 73J1800108 73J1800530

Distribution pattern

US Nationwide Distribution

device · product 5 of 8

Hudson RCI Sheridan Uncuffed: a) 2.0 mm, REF 5-10404 b) 2.5 mm, REF 5-10405 c) 3.0 mm, REF 5-10406 d) 3.5 mm, REF 5-10407 e) 4.0 mm, REF 5-10408 f) 4.5 mm, REF 5-10409 g) 5.0 mm, REF 5-10410 h) 5.5 mm, REF 5-10411 i) 6.0 mm, REF 5-10412 j) 6.5 mm, REF 5-10413 k) 7.0 mm, REF 5-10414 Product Usage: Tracheal tube/airway management

Z-2315-2019
Recall number
Z-2315-2019
Initiated
July 30, 2019
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
170740 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Code information

a) REF 5-10404 Batch numbers: 73L1600844 73A1700096 73A1700260 73B1700298 73C1700405 73F1700381 73F1700710 73H1700323 73H1700478 73M1700246 73A1800055 73B1800120 73E1800552 73J1800091 73L1800610 b) REF 5-10405 Batch numbers: 73L1600845 73A1700097 73A1700725 73B1700299 73F1700712 73G1700418 73H1700038 73H1700479 73J1700287 73A1800056 73A1800462 73B1800121 73E1800553 73F1800713 73H1800423 73H1800664 73K1800376 c) REF 5-10406 Batch numbers: 73L1600495 73B1700621 73D1700622 73E1700710 73F1700152 73G1700131 73H1700480 73J1700128 73J1700599 73K1700594 73L1700318 73M1700139 73M1700415 73A1800057 73A1800463 73A1800811 73B1800484 73C1800192 73D1800310 73D1800462 73E1800386 73E1800790 73F1800541 73G1800576 73H1800189 73H1800665 73J1800092 73L1800209 73L1800404 73L1800513 73L1800611 73L1800727 73M1800178 73M1800342 d) REF 5-10407 Batch numbers: 73K1600366 73L1600643 73A1700261 73D1700408 73G1700419 73H1700039 73K1700261 73K1700595 73M1700416 73A1800812 73C1800175 73E1800229 73F1800542 73G1800921 73K1800549 e) REF 5-10408 Batch numbers: 73K1600725 73L1600656 73B1700143 73C1700554 73D1700409 73E1700226 73E1700711 73F1700383 73F1700714 73H1700481 73J1700288 73J1700600 73M1700248 73B1800122 73B1800485 73B1800705 73D1800311 73D1800463 73E1800387 73F1800331 73G1800805 73H1800667 73J1800324 f) REF 5-10409 Batch numbers: 73K1600726 73L1600847 73A1700098 73A1700262 73C1700233 73C1700685 73D1700410 73E1700227 73F1700154 73F1700715 73H1700324 73J1700129 73J1700289 73K1700062 73K1700730 73M1700140 73A1800058 73B1800329 73B1800486 73B1800706 73C1800480 73D1800312 73E1800059 73E1800554 73F1800169 g) REF 5-10410 Batch numbers: 73K1600579 73L1600146 73L1600848 73A1700099 73B1700145 73B1700389 73C1700234 73C1700686 73D1700411 73E1700470 73F1700155 73F1700384 73F1700716 73H1700325 73J1700130 73K1700063 73K1700731 73M1700141 73B1800346 73B1800707 73C1800481 73E1800230 73E1800791 73F1800543 h) REF 5-10411 Batch numbers: 73J1600685 73K1600580 73L1600849 73A1700263 73C1700235 73C1700687 73D1700623 73E1700471 73F1700156 73F1700717 73G1700420 73H1700326 73J1700131 73K1700064 73K1700732 73L1700319 73M1700249 73A1800059 73B1800347 73B1800708 73D1800633 73E1800388 73F1800170 73G1800223 73G1800922 73H1800730 i) REF 5-10412 Batch numbers: 73J1600363 73K1600581 73L1600347 73L1600552 73L1600850 73M1600138 73A1700264 73B1700300 73C1700688 73E1700098 73E1700712 73G1700132 73H1700327 73J1700290 73K1700065 73K1700415 73L1700169 73L1700320 73M1700250 73A1800060 73B1800348 73B1800487 73C1800349 73C1800482 73D1800464 73E1800389 73F1800171 73G1800923 j) REF 5-10413 Batch numbers: 73M1600139 73B1700301 73E1700472 73G1700127 73K1700416 73A1800061 73B1800349 73B1800488 73D1800634 73F1800544 73G1800924 k) REF 5-10414 Batch numbers: 73A1700100 73F1700064 73L1800406

Distribution pattern

US Nationwide Distribution

device · product 6 of 8

Hudson RCI Sheridan/HVT: a) 5.0 mm, REF 5-10310 b) 5.5 mm, REF 5-10311 c) 6.0 mm, REF 5-10312 d) 6.5 mm, REF 5-10313 e) 7.0 mm, REF 5-10314 f) 7.5 mm, REF 5-10315 g) 8.0 mm, REF 5-10316 h) 8.5 mm, REF 5-10317 i) 9.0 mm, REF 5-10318 j) 10.0 mm, REF 5-10320 Product Usage: Tracheal tube/airway management

Z-2316-2019
Recall number
Z-2316-2019
Initiated
July 30, 2019
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
3375808 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Code information

a) REF 5-10310 Batch numbers: 73K1600356 73L1600336 73L1600486 73L1600836 73M1600132 73B1700134 73C1700227 73C1700676 73D1700243 73E1700091 73F1700013 73F1700145 73F1700702 73G1700410 73H1700471 73H1700777 73J1700593 73K1700254 73K1700723 73L1700661 73A1800282 73A1800664 73B1800341 73C1800186 73C1800563 73D1800303 73D1800454 73E1800071 73E1800378 73F1800706 73G1800567 73K1800540 73K1800541 b) REF 5-10311 Batch numbers: 73K1600357 73L1600337 73L1600487 73L1600837 73A1700253 73C1700677 73D1700126 73E1700092 73E1700459 73E1700221 73F1700374 73G1700411 73G1700590 73H1700472 73J1700459 73K1700255 73K1700724 73M1700239 73A1800283 73A1800809 73C1800187 73D1800132 73D1800304 73D1800455 73E1800379 73E1800784 73F1800536 73H1800183 c) REF 5-10312 Batch numbers: 73J1600355 73J1600564 73J1600751 73K1600137 73K1600571 73L1600138 73L1600338 73L1600488 73L1600650 73L1600838 73M1600133 73A1700091 73A1700254 73A1700721 73B1700136 73B1700296 73B1700402 73B1700617 73C1700402 73C1700678 73D1700127 73E1700093 73E1700460 73F1700137 73F1700538 73F1700703 73G1700218 73G1700591 73H1700318 73H1700473 73H1700778 73J1700127 73J1700460 73J1700594 73K1700057 73K1700409 73K1700587 73K1700725 73L1700498 73M1700240 73M1700450 73A1800284 73A1800442 73A1800665 73A1800810 73B1800342 73B1800702 73C1800188 73C1800564 73D1800059 73D1800133 73D1800305 73D1800456 73D1800629 73E1800072 73E1800381 73E1800785 73F1800163 73F1800707 73G1800118 73G1800218 73G1800568 73G1800799 73G1800911 73H1800184 73H1800420 73J1800072 73H1800724 73J1800663 73K1800163 73K1800369 73K1800456 73L1800799 d) REF 5-10313 Batch numbers: 73J1600356 73J1600357 73J1600565 73J1600752 73K1600138 73K1600572 73K1600573 73L1600139 73L1600339 73L1600489 73L1600651 73M1600134 73A1700092 73A1700255 73A1700404 73A1700643 73A1700722 73B1700137 73B1700403 73B1700618 73C1700228 73C1700550 73C1700679 73D1700615 73E1700094 73E1700222 73E1700461 73F1700014 73F1700375 73F1700539 73F1700704 73G1700412 73H1700319 73H1700474 73H1700594 73J1700283 73J1700461 73J1700595 73K1700058 73K1700410 73K1700588 73K1700726 73L1700311 73L1700499 73L1700662 73M1700241 73M1700425 73M1700451 73A1800043 73A1800285 73A1800666 73B1800117 73B1800480 73B1800703 73C1800476 73D1800134 73D1800306 73D1800457 73E1800073 73E1800227 73E1800548 73F1800328 73F1800708 73G1800119 73G1800219 73G1800800 e) REF 5-10314 Batch numbers: 73J1600358 73J1600359 73J1600360 73J1600753 73J1600754 73K1600139 73K1600140 73K1600141 73K1600142 73K1600359 73K1600360 73K1600576 73K1600574 73K1600575 73K1600723 73L1600340 73L1600490 73L1600491 73L1600839 73L1600840 73M1600135 73A1700093 73A1700094 73A1700095 73B1700138 73B1700139 73B1700297 73B1700404 73B1700405 73B1700406 73B1700407 73C1700403 73C1700404 73C1700551 73C1700552 73C1700680 73C1700681 73D1700616 73E1700095 73E1700096 73E1700242 73E1700462 73E1700463 73E1700703 73E1700705 73E1700706 73F1700015 73F1700016 73F1700146 73F1700147 73F1700148 73F1700149 73F1700540 73F1700541 73F1700542 73F1700543 73F1700705 73G1700143 73G1700125 73G1700220 73G1700221 73G1700222 73G1700219 73G1700592 73H1700024 73H1700025 73H1700475 73H1700476 73H1700595 73H1700596 73J1700148 73J1700284 73J1700285 73J1700596 73K1700059 73K1700256 73K1700257 73K1700258 73K1700589 73K1700727 73L1700223 73M1700205 73M1700242 73M1700243 73M1700244 73M1700426 73M1700437 73M1700438 73A1800293 73A1800294 73A1800295 73A1800429 73A1800798 73A1800799 73B1800343 73B1800344 73B1800345 73C1800344 73C1800345 73C1800346 73C1800477 73C1800565 73C1800566 73C1800567 73D1800630 73D1800631 73D1800632 73E1800074 73E1800075 73E1800382 73E1800383 73E1800549 73E1800550 73E1800786 73E1800787 73F1800709 73F1800711 73F1800710 73G1800120 73G1800121 73G1800149 73G1800220 73G1800487 73G1800636 73G1800637 73G1800638 73G1800913 73G1800914 73G1800915 73H1800422 73H1800726 73J1800088 73J1800089 73J1800354 73J1800509 73J1800510 73J1800508 73J1800651 73J1800665 f) REF 5-10315 Batch numbers: 73J1600361 73J1600362 73J1600566 73J1600567 73L1600492 73L1600652 73L1600653 73L1600686 73M1600136 73M1600137 73M1600267 73A1700257 73A1700258 73A1700405 73A1700724 73B1700140 73B1700631 73B1700632 73C1700229 73C1700230 73C1700231 73C1700682 73C1700707 73D1700140 73D1700244 73D1700245 73D1700268 73E1700223 73E1700224 73E1700225 73E1700464 73E1700465 73E1700466 73F1700279 73F1700377 73F1700378 73F1700379 73F1700376 73G1700203 73G1700223 73G1700413 73G1700414 73H1700320 73H1700303 73H1700597 73H1700780 73J1700462 73J1700463 73K1700259 73K1700411 73K1700412 73K1700729 73L1700312 73L1700313 73L1700314 73L1700315 73M1700430 73A1800431 73A1800667 73A1800668 73A1800669 73A1800670 73A1800794 73B1800481 73B1800714 73C1800568 73D1800135 73D1800136 73D1800285 73D1800307 73E1800076 73E1800228 73E1800384 73E1800385 73F1800164 73F1800329 73F1800330 73F1800537 73F1800538 73F1800539 73F1800540 73G1800570 73G1800802 73G1800803 73G1800917 73G1800918 73G1800919 73H1800072 73H1800073 73H1800186 73H1800659 73H1800660 73H1800727 73J1800090 73J1800325 73J1800326 73K1800164 73K1800321 73K1800351 73K1800352 g) REF 5-10316 Batch numbers: 73J1600568 73J1600755 73K1600577 73L1600143 73L1600341 73L1600342 73L1600343 73L1600555 73L1600654 73L1600841 73L1600842 73A1700413 73A1700414 73A1700654 73B1700408 73B1700619 73B1700620 73D1700246 73D1700416 73D1700417 73D1700418 73D1700617 73D1700618 73E1700707 73E1700708 73F1700018 73F1700563 73F1700706 73F1700707 73F1700708 73G1700415 73G1700416 73G1700593 73G1700594 73H1700321 73H1700477 73H1700781 73J1700444 73J1700464 73J1700598 73K1700413 73K1700590 73K1700591 73M1700122 73M1700123 73M1700124 73A1800053 73A1800054 73B1800693 73C1800189 73C1800190 73C1800191 73D1800290 73D1800458 73D1800459 73E1800788 73E1800789 73F1800071 73G1800221 73G1800222 73G1800639 73G1800571 73G1800572 73H1800435 73H1800436 73H1800661 73H1800662 73J1800332 73J1800333 73J1800666 73K1800124 73K1800165 73K1800166 73K1800167 73K1800227 73L1800480 h) REF 5-10317 Batch numbers: 73K1600364 73L1600344 73L1600655 73C1700683 73D1700619 73F1700544 73G1700417 73H1700322 73J1700286 73M1700024 73A1800299 73B1800716 73C1800569 73F1800165 73G1800920 73J1800511 73K1800546 i) REF 5-10318 Batch numbers: 73L1600144 73L1600493 73L1600701 73L1600843 73A1700259 73C1700232 73C1700684 73D1700247 73E1700097 73E1700468 73F1700150 73F1700380 73F1700709 73G1700595 73H1700170 73H1700598 73K1700060 73K1700260 73K1700593 73L1700316 73L1700663 73M1700245 73A1800286 73A1800443 73B1800119 73B1800482 73C1800347 73D1800308 73D1800460 73E1800551 73F1800166 73F1800712 73G1800123 73G1800573 73H1800187 73H1800663 73H1800728 73J1800322 73J1800667 73K1800547 j) REF 5-10320 Batch numbers: 73L1700500 73J1800512 73K1800168

Distribution pattern

US Nationwide Distribution

device · product 7 of 8

Sheridan/CF Novaplus 7.0 mm, REF V5-10114 Product Usage: Tracheal tube/airway management

Z-2317-2019
Recall number
Z-2317-2019
Initiated
July 30, 2019
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
77136 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Code information

Batch numbers: 73K1600156 73K1600735 73L1600501 73A1700120 73B1700321 73C1700425 73D1700630 73E1700504 73G1700146 73H1700053 73J1700307 73K1700085 73B1800223 73B1800371 73C1800372 73D1800655 73E1800579 73G1800627 73H1800203 73H1800429 73H1800758 73J1800118 73J1800696

Distribution pattern

US Nationwide Distribution

device · product 8 of 8

Sheridan/HVT Novaplus: a) 7.0 mm, REF V5-10314 b) 7.5 mm, REF V5-10315 c) 8.0 mm, REF V5-10316 d) 8.5 mm, REF V5-10317 Product Usage: Tracheal tube/airway management

Z-2318-2019
Recall number
Z-2318-2019
Initiated
July 30, 2019
Classification
Class I
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
1391004 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

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Reason for recall

Reported complaints indicate an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the endotracheal tube (ETT). Disconnection from the breathing circuit may result in insufficient oxygenation, requiring medical intervention.

Code information

a) 7.0 mm, REF V5-10314 Batch numbers: 73J1600387 73J1600388 73K1600157 73K1600603 73K1600604 73K1600736 73L1600367 73L1600368 73L1600502 73L1600870 73M1600165 73M1600270 73A1700121 73A1700122 73B1700322 73B1700428 73C1700426 73C1700576 73C1700577 73C1700702 73C1700703 73E1700106 73E1700107 73E1700108 73E1700239 73F1700560 73G1700147 73G1700148 73G1700302 73G1700303 73G1700623 73G1700624 73H1700055 73H1700497 73H1700568 73H1700628 73J1700309 73K1700086 73K1700087 73K1700616 73A1800296 73A1800430 73B1800218 73B1800372 73B1800373 73B1800374 73B1800512 73B1800513 73C1800373 73C1800574 73C1800575 73D1800656 73D1800657 73E1800580 73E1800581 73E1800809 73F1800723 73G1800107 73H1800205 73H1800456 73H1800457 73H1800759 73H1800760 73J1800120 73J1800534 73J1800697 b) 7.5 mm, REF V5-10315 Batch numbers: 73J1600389 73J1600580 73J1600581 73K1600158 73L1600260 73L1600518 73L1600672 73M1600268 73A1700289 73A1700290 73A1700741 73B1700165 73B1700638 73C1700265 73D1700137 73D1700138 73D1700266 73D1700267 73E1700240 73F1700281 73F1700365 73F1700414 73G1700237 73G1700437 73H1700056 73H1700352 73H1700629 73H1700796 73J1700443 73K1700435 73K1700436 73K1700754 73L1700672 73L1700673 73A1800687 73A1800795 73B1800514 73D1800158 73D1800286 73E1800098 73E1800309 73E1800312 73E1800407 73E1800408 73F1800191 73F1800192 73F1800362 73F1800363 73G1800595 73G1800831 73H1800078 73H1800688 73H1800761 73J1800327 73K1800322 c) 8.0 mm, REF V5-10316 Batch numbers: 73J1600582 73J1600772 73K1600605 73L1600174 73L1600369 73L1600370 73L1600673 73L1600871 73A1700428 73A1700661 73B1700625 73D1700430 73D1700431 73D1700432 73D1700631 73F1700038 73F1700039 73F1700734 73G1700438 73G1700625 73H1700353 73H1700499 73H1700797 73J1700144 73J1700493 73J1700610 73K1700617 73M1700150 73A1800070 73B1800728 73B1800729 73C1800205 73C1800207 73D1800291 73D1800483 73D1800484 73E1800810 73G1800234 73G1800596 73H1800458 73J1800334 73J1800698 73K1800195 d) 8.5 mm, REF V5-10317 Batch numbers: 73L1600674 73B1700639 73C1700704 73D1700632 73F1700561 73G1700439 73H1700354 73M1700025 73B1800730 73F1800193 73G1800019 73H1800093 73K1800574

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