Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm UPN: M00536700
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-0557-2020
- Quantity
- 271 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: 21483842 21512596 21724129 21806787 21973221 22307744 22460195 23073639 23492663 24271829
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.