Date Initiated by Firm |
November 03, 2017 |
Date Posted |
December 05, 2017 |
Recall Status1 |
Terminated 3 on November 04, 2019 |
Recall Number |
Z-0275-2018 |
Recall Event ID |
78607 |
510(K)Number |
K132641 K143077 K113260 K113778 K151667
|
Product Classification |
Catheter, thrombus retriever - Product Code NRY
|
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 |
Code Information |
Lot Numbers: QXC10200044, exp. date 28-Aug-18; QXC10200043, exp. date 28-Aug-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 |
2 units |
Distribution |
International Distribution to: Germany, Slovakia and Israel. |
Total Product Life Cycle |
TPLC Device Report
|
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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
|