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Recall Observatory FDA recall evidence

Device product

Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,150 cm, 6 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm, UPN M0033PK62523002 Stroke intervention kit

Z-0275-2018

November 03, 2017

Class II

Product summary

Firm
Stryker Neurovascular
Event
Event 78607
Status
Terminated
Classification
Class II
Quantity
2 units
Official record key
device-enforcement:Z-0275-2018

Official wording

Reason: Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.

Code information: Lot Numbers: QXC10200044, exp. date 28-Aug-18; QXC10200043, exp. date 28-Aug-18

Distribution pattern: International Distribution to: Germany, Slovakia and Israel.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were manufactured using a carton sleeve where the sleeve label contents did not match the physical contents within the pack.