Recall Z-0275-2018
Stryker Neurovascular · initiated November 3, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot Numbers: QXC10200044, exp. date 28-Aug-18; QXC10200043, exp. date 28-Aug-18
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.
FDA-determined cause: Labeling Change Control
Action taken
The firm, Stryker Neurovascular, sent an "Urgent Medical Device Voluntary Recall Immediate Action Required" letter initiating their recall on 11/01/2017. The letter described the product, problem and actions to be taken. The consignees were instructed to immediately check internal inventory; remove and discard the procedure pack carton sleeve; circulate notice; maintain awareness of notice internally until all required actions have been completed with your facility; inform Stryker of any subject devices distributed to other organization, and complete and return customer response form to your nominated Stryker Representative or to NVFieldActions@stryker.com. If you have any questions, call 510-413-2593; email: geraldine.ahern@stryker.com or 510-413-2900.
Details
- Recall number
- Z-0275-2018
- Initiated
- November 3, 2017
- Posted by FDA
- December 5, 2017
- Terminated
- November 4, 2019
- Product code
- NRY – Catheter, Thrombus Retriever
- Quantity
- 2 units
- Distribution
- International Distribution to: Germany, Slovakia and Israel.
- Recalling firm
- Stryker Neurovascular, Fremont, CA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0276-2018 Class II | Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 4 mm, 20 mm…Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were… | 11/03/2017Terminated |
| Z-0277-2018 Class II | Trevo(TM) XP ProVue Procedure Pack, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm…Stryker Neurovascular has become aware that some 3-Pack Stroke Fast Packs and Trevo Procedure Packs were… | 11/03/2017Terminated |