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Recall Observatory FDA recall evidence

Device product

Various eye packs, cataract packs

Z-1705-2022

June 16, 2022

Class II

Product summary

Firm
American Contract Systems, Inc.
Event
Event 90574
Status
Ongoing
Classification
Class II
Quantity
4 units
Official record key
device-enforcement:Z-1705-2022

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) BLSE37K, 2106292, 820211, 15017475-004 2) MECA21P, 2108022, 786211, 44234851-005 3) CMEY17AD, 2108301, 760211, 15101886-004 4) CXEY80X, 2109083, 749211, 15109749-004

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.