Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm UPN: M00536630
This recall has been terminated (originally issued November 25, 2019).
- Company
- Boston Scientific Corporation
- Recall Initiated
- October 21, 2019
- Posted
- November 25, 2019
- Terminated
- December 20, 2023
- Recall Number
- Z-0550-2020
- Quantity
- 542 units
- Firm Location
- Marlborough, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Product manufactured between September 29, 2017 and September 12, 2019 have been labeled with a 36-month shelf life rather than the approved 18-month shelf life
Distribution
Nationwide Foreign: Austria Australia Belgium Bulgaria Croatia Czech Rep Denmark Finland France Germany Great Britain Italy Japan Pakistan Poland Russian Fed. Slovakia South Africa Spain Sweden Switzerland Thailand Turkey
Lot / Code Info
Lot Numbers: 21483840 21512594 21724125 21833851 22007180 22195528 22212528 22647190 22828072 23000367 23257632 23578453 23615959 23796006 24167478 24229865 24396823
Root Cause
Incorrect or no expiration date
Action Taken
Boston Scientific issued Notifications to consignees via Federal Express Priority mail on October 21, 2019. The notification instructs the account to check their inventory remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form.