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Recall Observatory FDA recall evidence

Device product

Various C-section packs

Z-1703-2022

June 16, 2022

Class II

Product summary

Firm
American Contract Systems, Inc.
Event
Event 90574
Status
Ongoing
Classification
Class II
Quantity
24 units
Official record key
device-enforcement:Z-1703-2022

Official wording

Reason: Product was exposed to multiple sterilization cycles without validation for multiple exposures.

Code information: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product was exposed to multiple sterilization cycles without validation for multiple exposures.