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U.S. Department of Health and Human Services

Class 2 Device Recall Advanix Pancreatic Stent

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  Class 2 Device Recall Advanix Pancreatic Stent see related information
Date Initiated by Firm October 21, 2019
Date Posted November 25, 2019
Recall Status1 Terminated 3 on December 20, 2023
Recall Number Z-0551-2020
Recall Event ID 84150
510(K)Number K133700  
Product Classification Stents, drains and dilators for the biliary ducts - Product Code FGE
Product Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640
Code Information Lot Codes: 21973220  22522254  23837823  
Recalling Firm/
Manufacturer		 Boston Scientific Corporation
300 Boston Scientific Way
Marlborough MA 01752-1291
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 54 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
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.
510(K) Database 510(K)s with Product Code = FGE and Original Applicant = Boston Scientific Corporation
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