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Recall Observatory FDA recall evidence

Device product

Acuject Variable Injection Needle

Z-2089-2019

June 14, 2019

Class II

Product summary

Firm
Wilson-Cook Medical Inc.
Event
Event 83135
Status
Terminated
Classification
Class II
Quantity
24
Official record key
device-enforcement:Z-2089-2019

Official wording

Reason: Potential for occluded injection needles.

Code information: Lot Code W413079; Catalog Number VIN-25; Expiration Date 10/24/2021; UDI Number (01)00827002225268(17)211024(10)W4136079

Distribution pattern: Distributed to China

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for occluded injection needles.