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Recall Observatory FDA recall evidence

Device product

MEDLINE convenience kits labeled as: 1) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907I; 2) LAKELAND SINGLE BASIN PACK-LF, REF DYNJ0619907K; 3) LKLND SNGL BASIN PK RFID-LF, REF DYNJ0619907L; 4) BASIN SET W/ RING BASIN, REF DYNJ06966M; 5) OPEN HEART C--BASIN PACK-LF, REF DYNJ0867331G; 6) TOTAL KNEE BASIN B PACK-LF, REF DYNJ0867555L; 7) ST. ANNE'S MINOR BASIN PACK, REF DYNJ24622K; 8) ST. ANNE'S MAJOR BASIN SET UP, REF DYNJ24628M; 9) MAJOR BASIN SET, REF DYNJ41285B; 10) BASIN PACK, REF DYNJ50123D; 11) MAJOR BASIN TRAY, REF DYNJ54461F; 12) MAJOR BASIN TRAY, REF DYNJ54461G; 13) MAJOR BASIN TRAY, REF DYNJ54461I; 14) TR-MINOR KIT-LF, REF DYNJ54801F; 15) TR-MAJOR KIT-LF, REF DYNJ54802I; 16) MAJOR BASIN PACK, REF DYNJ59816A; 17) SINGLE BASIN PACK ST VINCENT, REF DYNJ60529D; 18) BASIN PACK, REF DYNJ60812B; 19) BASIN PACK SH, REF DYNJ60812C; 20) PLASTIC BASIN PACK, REF DYNJ63883C; 21) MINOR PACK, REF DYNJ63961D; 22) OSC BREAST PACK, REF DYNJ65808B; 23) OSC BASIN PACK, REF DYNJ68217A; 24) DELNOR VASCULAR BASIN PACK, REF DYNJ82257; 25) DELNOR BASIN PACK, REF DYNJ82267; 26) STAZ MAJOR BASIN, REF DYNJ909785; 27) LUMBAR, REF DYNJ909923

Z-0634-2025

October 09, 2024

Class II

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 95621
Status
Ongoing
Classification
Class II
Quantity
14388 units
Official record key
device-enforcement:Z-0634-2025

Official wording

Reason: Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Code information: 1) REF DYNJ0619907I, UDI/DI 10195327239480 (each) 40195327239481 (case), Lot Numbers: 22IMG033; 2) REF DYNJ0619907K, UDI/DI 10195327295905 (each) 40195327295906 (case), Lot Numbers: 22LME111; 3) REF DYNJ0619907L, UDI/DI 10195327333119 (each) 40195327333110 (case), Lot Numbers: 23JBH171, 23HBV761, 23FMI052; 4) REF DYNJ06966M, UDI/DI 10195327349059 (each) 40195327349050 (case), Lot Numbers: 23EBR799, 23IBI141, 23KBC445, 23LBJ670; 5) REF DYNJ0867331G, UDI/DI 10195327118433 (each) 40195327118434 (case), Lot Numbers: 22EDA376, 22FDA407; 6) REF DYNJ0867555L, UDI/DI 10195327202613 (each) 40195327202614 (case), Lot Numbers: 23DDB147; 7) REF DYNJ24622K, UDI/DI 10195327109127 (each) 40195327109128 (case), Lot Numbers: 23ABN514, 22EBS282, 22EBE400, 23CBV810, 23CBH097, 23EBT659; 8) REF DYNJ24628M, UDI/DI 10195327109134 (each) 40195327109135 (case), Lot Numbers: 22FLA375, 22DLA993, 22ILA590, 23GLA918, 23FLA366, 23DLA800, 23BLA536, 22JLA323, 23CLB087; 9) REF DYNJ41285B, UDI/DI 10195327515546 (each) 40195327515547 (case), Lot Numbers: 23KBF131; 10) REF DYNJ50123D, UDI/DI 10195327201999 (each) 40195327201990 (case), Lot Numbers: 22KBI121, 22KBI122, 23CBT112, 23EBB417; 11) REF DYNJ54461F, UDI/DI 10195327155728 (each) 40195327155729 (case), Lot Numbers: 22IMA730, 22LMG820, 23EMB339, 23DMD912, 23HMG790, 23HMC613, 23GMF360, 23IMH847; 12) REF DYNJ54461G, UDI/DI 10195327543570 (each) 40195327543571 (case), Lot Numbers: 23KMA747, 23KBS302, 24ABI360; 13) REF DYNJ54461I, UDI/DI 10195327613730 (each) 40195327613731 (case), Lot Numbers: 24BBG122, 24ABS064, 24DBG019; 14) REF DYNJ54801F, UDI/DI 10195327450861 (each) 40195327450862 (case), Lot Numbers: 23HDC012; 15) REF DYNJ54802I, UDI/DI 10195327450878 (each) 40195327450879 (case), Lot Numbers: 23FDC386, 23IDA377; 16) REF DYNJ59816A, UDI/DI 10195327331573 (each) 40195327331574 (case), Lot Numbers: 23CBV819, 23EBF888; 17) REF DYNJ60529D, UDI/DI 10195327523411 (each) 40195327523412 (case), Lot Numbers: 23JMH503; 18) REF DYNJ60812B, UDI/DI 10195327454630 (each) 40195327454631 (case), Lot Numbers: 23HBL174; 19) REF DYNJ60812C, UDI/DI 10195327521226 (each) 40195327521227 (case), Lot Numbers: 23KBE930, 23JBN323, 23LBN436; 20) REF DYNJ63883C, UDI/DI 10195327221829 (each) 40195327221820 (case), Lot Numbers: 23IDA838, 23GDA969, 23ADA553, 22JDC142, 23KDA710, 24ADB347, 23CDB848, 23EDA013, 24CDA880; 21) REF DYNJ63961D, UDI/DI 10195327428877 (each) 40195327428878 (case), Lot Numbers: 23HDC162, 23GDB814, 23JDA825, 24BDA028, 24DDA624; 22) REF DYNJ65808B, UDI/DI 10195327273552 (each) 40195327273553 (case), Lot Numbers: 23AMI184, 23AMA558; 23) REF DYNJ68217A, UDI/DI 10195327352523 (each) 40195327352524 (case), Lot Numbers: 23CME053, 23FMG407; 24) REF DYNJ82257, UDI/DI 10195327181659 (each) 40195327181650 (case), Lot Numbers: 23IMA316; 25) REF DYNJ82267, UDI/DI 10195327182229 (each) 40195327182220 (case), Lot Numbers: 23GDB214, 23IDC201; 26) REF DYNJ909785, UDI/DI 10195327475819 (each) 40195327475810 (case), Lot Numbers: 23HBU592, 23IBN694; 27) REF DYNJ909923, UDI/DI 10195327504533 (each) 40195327504534 (case), Lot Numbers: 23LMB294, 24BMC919

Distribution pattern: US Nationwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.

Field note

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