Stroke Fast Pack(TM), Trevo(TM) XP, TREVO(TM) XP PROVUE RETRIEVER, 6 mm, 25 mm; Excelsior(TM) XT-27(tm), MICROCATHETER,1
FDA device recall Z-0275-2018 · posted 2017-12-05 · Terminated
Recall details
- Recalling firm
- Stryker Neurovascular
- 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.
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- NRY
- Quantity affected
- 2 units
- Distribution
- International Distribution to: Germany, Slovakia and Israel.
- Date initiated
- 2017-11-03
- Date posted
- 2017-12-05
- Date terminated
- 2019-11-04
- Location
- Fremont, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AXS Catalyst Distal Access Catheter 058x115cm, AXS Catalyst Distal Access Catheter 058x132cm, AXS Catalyst Distal Access Catheter 060x132cm (K151667) | Stryker | 2015-11-13 |
| Trevo XP ProVue Retriever (6X25mm) (K143077) | Concentric Medical, Inc. | 2015-04-06 |
| MODIFIED TREVO PROVUE RETRIEVER (K132641) | Concentric Medical, Inc. | 2014-01-13 |
| EXCELSIOR XT-27 MICROCATHETER (K113778) | Stryker Neurovascular | 2012-04-20 |
| MODIFIED CONCENTIRC MICROCATHETER (K113260) | Concentric Medical, Inc. | 2012-03-09 |