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Recall Observatory FDA recall evidence

Device product

American Contract Systems Cataract Pack convenience kit

Z-2522-2024

May 06, 2024

Class II

Product summary

Firm
American Contract Systems, Inc.
Event
Event 94908
Status
Ongoing
Classification
Class II
Quantity
3
Official record key
device-enforcement:Z-2522-2024

Official wording

Reason: Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber

Code information: UDI-DI 00191072188762; Lot 988241; Exp. Date 1/12/2025.

Distribution pattern: US Nationwide distribution in the states of CA, KS, ME, MN, MO, NE, and SD.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product released with insufficient aeration time impacting the kits sterilized on the same cycle or in the same aeration chamber

Field note

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