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Recall Observatory FDA recall evidence

Device product

Clean Catch Urine Kit NS 178489, AHMU58A

Z-1276-2022

May 02, 2022

Class I

Product summary

Firm
American Contract Systems, Inc.
Event
Event 90324
Status
Ongoing
Classification
Class I
Quantity
274,400 kits total
Official record key
device-enforcement:Z-1276-2022

Official wording

Reason: Affected products were assembled off-site by individuals who may not have been properly trained.

Code information: UDI-DI: 00191072120557 Lots 891211, 737211, 699211, 986221

Distribution pattern: US distribution in the state of Minnesota.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Affected products were assembled off-site by individuals who may not have been properly trained.