Boston Scientific Recalls Flexima Duodenal Bend Biliary Stent Due to Packaging Defects
Boston Scientific is recalling 18 units of Flexima Duodenal Bend Biliary Stents due to potential sterile barrier packaging seal defects.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves potential packaging seal defects which are considered a low-risk contamination or labeling/packaging issue without reported injuries.
Plain-English summary
Boston Scientific Corporation is recalling 18 units of the Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210. The recall is being conducted because the sterile barrier may contain packaging seal defects.
The affected products, identified by Lot 22960201, were distributed to facilities in the United States and several foreign countries. The specific US states listed include Alabama, California, Illinois, Maryland, Pennsylvania, Tennessee, Texas, Utah, and Wisconsin. The products were also distributed to Austria, Ecuador, Germany, Italy, Portugal, Romania, Saudi Arabia, and Spain.
Healthcare providers and facilities should stop using the affected units and contact Boston Scientific for further instructions regarding the return or replacement of the product.
The recalled product
- Product
- Flexima Duodenal Bend Biliary Stent with Delivery System, 7F (2.3mm) x7cm, Material Number M00539210
- Manufacturer
- Boston Scientific Corporation
- Category
- Medical Device — Biliary Stent
- Affected units
- 18
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot 22960201
Distribution
Part of a larger recall action
This product is one of 2 recalled by Boston Scientific Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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