Various hysterectomy recall
Various hysterectomy, vaginal packs
Why was Various hysterectomy recalled?
Product was exposed to multiple sterilization cycles without validation for multiple exposures.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Various hysterectomy, vaginal packs
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 29 units
- Distribution
- 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
- Recall date
- September 14, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)