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Recall Observatory FDA recall evidence

Device product

Stroke Fast Pack(TM) Trevo XP ProVue Retriever 3 x 20, Trevo Pro 14 Microcatheter, AXS Catalyst 060x132CM - US, UPN M0033PK32021001

Z-2799-2017

June 26, 2017

Class II

Product summary

Firm
Stryker Neurovascular
Event
Event 77671
Status
Terminated
Classification
Class II
Quantity
43 packs
Official record key
device-enforcement:Z-2799-2017

Official wording

Reason: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack.

Code information: Lot Numbers: QPC20107530, QPC20107745, QPC20107814, QPC20110247

Distribution pattern: nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs were manufactured using a carton sleeve where the pre-printed contents on the back of the sleeve did not match the physical contents of the pack.