Z-1702-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2022
- Initiation Date
- June 16, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 29 units
Product Description
Various hysterectomy, vaginal packs
Reason for Recall
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
Distribution Pattern
Distribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
Code Information
Tray Number, Sterilization Lot, Lot Number, Bag Serial Number 1) LSRGYOSCOPYG, 2104281, 888211, 63995389 2) LSRLMGLAPF, 2105282, 856211, 44252282 3) LSRHPGYND, 2106092, 847211, 14887375 4) LSRHPGYND, 2106092, 847211, 14887374 5) LSRHPGYND, 2106092, 847211, 14887373 6) AMJL22Z, 2106112, 840211, 64176443 7) FDMN88N, 2107013, 821211, 64168939 8) MMJL16C, 2108023, 791211, 44180974 9) UIGY37AA, 2108033, 789211, 64104498 10) FHGG12V, 2109131, 748211, 64223133 11) BHOB33G, 2104191, 894211, 14870011-004 12) AHHY33M, 2105131, 867211, 14874336-004 13) MEHY02M, 2106152, 834211, 15003746-004 14) MEHY02M, 2106152, 834211, 15003740-004 15) MEHY02M, 2106152, 834211, 15003713-004 16) MEHY02M, 2106152, 834211, 15003709-004 17) MEHY02M, 2106152, 834211, 15003704-004 18) MEHY02M, 2106152, 834211, 15001377-004 19) MEHY02M, 2106152, 834211, 15003712-004 20) CXVG89X, 2106171, 833211, 43996010-005 21) SLGG63G, 2106282, 821211, 64071565-006 22) BHVR88A, 2106291, 828211, 64090094-006 23) UMVG16A, 2109031, 756211, 63998597-006 24) BHVP17H, 2106071, 845211, 14901608-004 25) BHVP17H, 2106071, 845211, 14901609-004 26) BHVP17H, 2108051, 785211, 15028595-004 27) BHVP17H, 2109031, 755211, 15023691-004 28) MCGY26E, 2109071, 754211, 44261563-005 29) MPGY64E, 2109081, 754211, 44261561-005