Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
This recall has been terminated (originally issued December 26, 2018).
- Company
- Boston Scientific Corporation
- Recall Initiated
- December 26, 2018
- Terminated
- April 17, 2020
- Recall Number
- Z-1013-2019
- Quantity
- 18 units
- Firm Location
- Marlborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
The sterile barrier may contain packaging seal defects.
Distribution
The products were distributed to the following US states: AL, CA, IL, MD, PA, TN, TX, UT, and WI. The products were distributed to the following foreign countries: Austria, Ecuador, Germany, Italy, Portugal, Romania, Saudi Arabia, and Spain.
Lot / Code Info
Lot 22960201
Root Cause
Other
Action Taken
Urgent Medical Device Product Removal notification letters dated 12/26/18 were sent to customers.
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