Z-0275-2018 Class II Terminated

Recalled by Stryker Neurovascular — Fremont, CA

Recall Details

Product Type
Devices
Report Date
December 27, 2017
Initiation Date
November 3, 2017
Termination Date
November 4, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2 units

Product Description

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

Reason for Recall

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.

Distribution Pattern

International Distribution to: Germany, Slovakia and Israel.

Code Information

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