Date Initiated by Firm | November 28, 2017 |
Create Date | January 14, 2018 |
Recall Status1 |
Terminated 3 on April 28, 2020 |
Recall Number | Z-0347-2018 |
Recall Event ID |
78716 |
510(K)Number | K113260 K132641 |
Product Classification |
Catheter, thrombus retriever - Product Code NRY
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Product | Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter |
Code Information |
UPN/Model No. 80052; Lot 63034 |
Recalling Firm/ Manufacturer |
Stryker Neurovascular 47900 Bayside Pkwy Fremont CA 94538-6515
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Manufacturer Reason for Recall | Stryker Neurovascular has become aware that at least 1 (one) Trevo XP Provue System was manufactured where the carton sleeve did not match the physical contents of the pack. |
FDA Determined Cause 2 | Packaging process control |
Action | The affected consignees will be notified via letter sent a courier beginning 11/28/17. A response form has been provided which customers have been asked to complete, and correct affected product is being requested. |
Distribution | OUS only - NL, FR, IT, DE, BE |
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.
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510(K) Database | 510(K)s with Product Code = NRY
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