Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm UPN: M00536730
FDA device recall Z-0560-2020 · posted 2019-11-25 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- 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
- 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.
- Root cause
- Incorrect or no expiration date
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 35 units
- 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 Switze
- Date initiated
- 2019-10-21
- Date posted
- 2019-11-25
- Date terminated
- 2023-12-20
- Location
- Marlborough, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS (K133700) | Boston Scientific Corporation | 2014-05-14 |