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Recall Observatory FDA recall evidence

Device product

Gammex Non-Latex PI Green PI-KARE Skin-friendly PI Technology polyisoprene surgical gloves 7 1/2

Z-0838-2022

February 19, 2022

Class II

Product summary

Firm
Ansell Healthcare Products LLC
Event
Event 89691
Status
Ongoing
Classification
Class II
Quantity
74 cases
Official record key
device-enforcement:Z-0838-2022

Official wording

Reason: Transport company failed to stop at the border for required FDA inspection.

Code information: Model Number: 20685275 UDI Code: 00884792385244 Lot Number: 2107481604

Distribution pattern: U.S.: AZ, CA, NV, TX, UT and WA O.U.S.: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Transport company failed to stop at the border for required FDA inspection.