Class 2 Device Recall Stroke Fast Pack(TM)

• Date Initiated by Firm: November 03, 2017
• Date Posted: December 05, 2017
• Recall Status: Terminated on November 04, 2019
• Recall Number: Z-0277-2018
• Recall Event ID: 78607
• 510(K)Number: K113260 K113778 K132641 K143077 K151667
• Product Classification: Catheter, thrombus retriever - Product Code NRY
• Product: 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
• Code Information: Lot Number QX10100894. Exp. Date 28-Oct-18
• Recalling Firm/ Manufacturer: Stryker Neurovascular; 47900 Bayside Pkwy; Fremont CA 94538-6515
• For Additional Information Contact: Angela Beckman; 510-413-2900
• Manufacturer 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: 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.
• Quantity in Commerce: 1 unit
• Distribution: International Distribution to: Germany, Slovakia and Israel.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = NRY; 510(K)s with Product Code = NRY; 510(K)s with Product Code = NRY