The Instructions for Use (IFU) for: Carotid Patch and Gelsoft Patch vascular patches. FSN says Tapered Carotid Patch 920875t
- Recall Initiated
- July 8, 2021
- Terminated
- August 19, 2024
- Recall Number
- Z-2543-2021
- Quantity
- 159 total vascular grafts and patches
Reason for Recall
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Distribution
Distribution was made to PR and Guam.
Lot / Code Info
To be reported.
Root Cause
Under Investigation by firm
Action Taken
The recalling firm sent emails on 7/8/2021 to the two distributors that contained the Field Safety Notice and the correct IFU to be supplied with products distributed to the United States.
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