Date Initiated by Firm | October 21, 2019 |
Date Posted | November 25, 2019 |
Recall Status1 |
Terminated 3 on December 20, 2023 |
Recall Number | Z-0558-2020 |
Recall Event ID |
84150 |
510(K)Number | K133700 |
Product Classification |
Stents, drains and dilators for the biliary ducts - Product Code FGE
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Product | Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm
UPN: M00536710 |
Code Information |
Lot Numbers: 21750674 22036150 22647191 23902873 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 300 Boston Scientific Way Marlborough MA 01752-1291
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For Additional Information Contact | Nicole Pshon 763-494-1556 |
Manufacturer 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 |
FDA Determined Cause 2 | Incorrect or no expiration date |
Action | 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. |
Quantity in Commerce | 66 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 |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = FGE
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