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Recall Observatory FDA recall evidence

Device product

Various ob/gyn packs

Z-1701-2022

June 16, 2022

Class II

Product summary

Firm
American Contract Systems, Inc.
Event
Event 90574
Status
Ongoing
Classification
Class II
Quantity
15 units
Official record key
device-enforcement:Z-1701-2022

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) LSROBDELIVC, 2104091, 904211, 14531604 2) LSRVAGDELIVC, 2106011, 863211, 44252284 3) LSRVAGDELIVC, 2106011, 863211, 44135283 4) LSRCFHVAGDC, 2108042, 791211, 64123598 5) LSRCFHVAGDC, 2108042, 791211, 64123599 6) LSRCFHVAGDC, 2108042, 791211, 64123597 7) LSRVAGDELIVC, 2108181, 776211, 44139780 8) LSROBDELIVC, 2109231, 743211, 64319309 9) UPVD01G, 2109211, 741211, 15187693 10) MEVG08P, 2105132, 873211, 14874335-004 11) SLOB77F, 2108101, 779211, 15093748-004 12) MEVG08Q, 2108192, 770211, 15103947-004 13) BHVG89C, 2104291, 887211, 14962314-004 14) BHVG89C, 2106303, 827211, 14956518-004 15) AGOB35D, 2107221, 799211, 64183198-006

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.