Z-0276-2018 Class II Terminated
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, 4 mm, 20 mm, ; Trevo(TM) Pro 18, TREVO PRO 18 MICROCATHETER, 0.021 in ID, 150 cm; AXS Catalyst(TM) 6, Distal Access Catheter, 0.060 in, 132 cm; UPN M0033PK42022002 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 Number QPC30200039, Exp. Date 28-Aug-18; QPC30200114, Exp. Date 28-Mar18