Z-0277-2018 Class II Terminated
FDA device recall Z-0277-2018 was initiated by Stryker Neurovascular on November 3, 2017 and is designated Class II. 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 … The recall status is terminated (terminated November 4, 2019). Affected quantity: 1 unit.
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
- 1 unit
Product Description
Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm, .Excelsior(TM) XT-27(TM) 1 TIP STRAIGHT, 150 cm, 6 cm, Microcatheter; UPN 93068 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 QX10100894. Exp. Date 28-Oct-18