Product Safety Recalls

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American Contract Systems, Inc. Recall 90574

Description: Various ob/gyn packs

American Contract Systems, Inc. Recall 90574 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1701-2022
Event ID90574
Event DescriptionVarious ob/gyn packs
Product TypeDevices
DistributionDistribution within the United States to health systems and distributors in AZ, FL, IA, IL, MA, MN, MO, OH, NE, PA, RI, SD, and TX
Quantity15 units
Recall ReasonProduct was exposed to multiple sterilization cycles without validation for multiple exposures.
Device Classification20220914
Device Code InfoTray 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
Center Classification Date20220908
Recall Initiation Date20220616
Recalling FirmAmerican Contract Systems, Inc.
Initial Notification E-Mail
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