Trevo XP ProVue System kit containing 1) Trevo XP ProVue Retriever, 4x20mm and 2) Trevo Pro18 Microcatheter
This recall has been terminated (originally issued November 28, 2017).
- Company
- Stryker Neurovascular
- Recall Initiated
- November 28, 2017
- Terminated
- April 28, 2020
- Recall Number
- Z-0347-2018
- Firm Location
- Fremont, CA
- Official Source
- View on FDA website ↗
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.
Distribution
OUS only - NL, FR, IT, DE, BE
Lot / Code Info
UPN/Model No. 80052; Lot 63034
Root Cause
Packaging process control
Action Taken
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.
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