Z-0634-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- December 11, 2024
- Initiation Date
- October 9, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14388 units
Product Description
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
Reason for Recall
Medline is recalling medical convenience manufactured using certain lots of SafeAir Smoke Evacuation Pencil which were subsequently recalled by Stryker.
Distribution Pattern
US Nationwide distribution.
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