—#159880

Product

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

FDA product code: NRY — Catheter, Thrombus Retriever
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K113260, K113778, K132641, K143077, K151667
Affected lot / code info: Lot Number QPC30200039, Exp. Date 28-Aug-18; QPC30200114, Exp. Date 28-Mar18

Why it was recalled

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.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Stryker Neurovascular
Address: 47900 Bayside Pkwy, Fremont, California 94538-6515

Distribution

Distribution pattern: International Distribution to: Germany, Slovakia and Israel.

Timeline

Recall initiated: 2017-11-03
Posted by FDA: 2017-12-05
Terminated: 2019-11-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #159880. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.