Flexima Duodenal Bend Biliary Stent with Delivery recall: Sterility Concern
Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
Why was Flexima Duodenal Bend Biliary Stent with Delivery recalled?
The sterile barrier may contain packaging seal defects.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 22960201
- Product
- Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
- Recalling firm
- Boston Scientific Corporation
- Quantity
- 18 units
- Distribution
- The products were distributed to the following US states: AL, CA, IL, MD, PA, TN, TX, UT, and WI. The products were distributed to the following foreign countries: Austria, Ecuador, Germany, Italy, Portugal, Romania, Saudi Arabia, and Spain.
- Recall date
- March 20, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)