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U.S. Department of Health and Human Services

Class 2 Device Recall Stroke Fast Pack(TM)

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  Class 2 Device Recall Stroke Fast Pack(TM) see related information
Date Initiated by Firm November 03, 2017
Date Posted December 05, 2017
Recall Status1 Terminated 3 on November 04, 2019
Recall Number Z-0277-2018
Recall Event ID 78607
510(K)Number K132641  K143077  K113260  K113778  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 2		 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 and Original Applicant = CONCENTRIC MEDICAL, INC.
510(K)s with Product Code = NRY and Original Applicant = Stryker
510(K)s with Product Code = NRY and Original Applicant = STRYKER NEUROVASCULAR
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