Various C-section packs recall
Various C-section packs
Why was Various C-section packs 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) LSRHPCSECTB, 2106301, 826211, 64124711 2) FHCP08U, 2107143, 807211, 64166455 3) LMSE38N, 2108202, 770211, 64231900 4) CFCS39G, 2108243, 768211, 64232041 5) IHCS29AA, 2109272, 733211, 64214921 6) CXCS92U, 2106191, 830211, 64071586-006 7) BHCS88D, 2104163, 897211, 64072275-006 8) BHCS88D, 2104163, 897211, 64072274-006 9) BHCS88D, 2104163, 897211, 64072275-006 10) BHCS88D, 2105151, 869211, 64067191-006 11) BHCS88D, 2106091, 848211, 64045555-006 12) BHCS88D, 2106232, 835211, 64091025-006 13) BHCS88D, 2106232, 835211, 64091024-006 14) BHCS88D, 2107061, 835211, 64090343-006 15) BHCS88D, 2107132, 811211, 64089826-006 16) BHCS88D, 2107132, 811211, 64089827-006 17) BHCS88D, 2107132, 811211, 64089828-006 18) BHCS88D, 2107161, 806211, 64088821-006 19) BHCS88D, 2107161, 806211, 64088822-006 20) BHCS88D, 2108171, 777211, 64092742-006 21) BHCS88D, 2109072, 758211, 63997845-006 22) BHCS88D, 2109072, 758211, 63997846-006 23) SWCS92K, 2107151, 811211, 64129480-006 24) SSCS25D, 2108171, 774211, 64139013-006
- Product
- Various C-section packs
- Recalling firm
- American Contract Systems, Inc.
- Quantity
- 24 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)