Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650
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-0552-2020
- Quantity
- 940 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: 21187998 21285271 21337147 21483841 21512595 21662812 21724126 21833852 21922988 22036149 22136471 22307745 22359735 22613955 22700891 23035017 23295961 23492660 23541961 24006978 24271828 24383293 24411526
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.