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Recall Observatory FDA recall evidence

Device product

Various ENT Packs

Z-1693-2022

June 16, 2022

Class II

Product summary

Firm
American Contract Systems, Inc.
Event
Event 90574
Status
Ongoing
Classification
Class II
Quantity
3 units
Official record key
device-enforcement:Z-1693-2022

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) LSRHPENTLHA, 2106181, 838211, 14882942 2) MREN03G, 2104262, 887211, 14934943 3) COEN27K, 2108102, 779211, 15093749-004

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.