Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680
Reported: December 4, 2019 Initiated: October 21, 2019 #Z-0555-2020
Product Description
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680
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
Details
- Recalling Firm
- Boston Scientific Corporation
- Units Affected
- 222 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 Switzerland Thailand Turkey
- Location
- Marlborough, MA
Frequently Asked Questions
What product was recalled? ▼
Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680. Recalled by Boston Scientific Corporation. Units affected: 222 units.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 4, 2019. Severity: Moderate. Recall number: Z-0555-2020.
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