Boston Scientific Pancreatic Stent Recall Due to Incorrect Shelf Life Labeling
Boston Scientific is recalling 940 Advanix Pancreatic Stents because they were labeled with a 36-month shelf life instead of the approved 18-month shelf life.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The specific defect is a labeling error regarding shelf life, which fits the criteria for a moderate severity recall involving minor labeling errors or low-risk contamination.
Plain-English summary
Boston Scientific Corporation is recalling 940 units of the Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm (UPN: M00536650). The recall involves units manufactured between September 29, 2017, and September 12, 2019.
The reason for the recall is that the affected products were labeled with a 36-month shelf life rather than the approved 18-month shelf life. The products were distributed nationwide and to various foreign countries, including Austria, Australia, Belgium, Bulgaria, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Italy, Japan, Pakistan, Poland, Russian Federation, Slovakia, South Africa, Spain, Sweden, Switzerland, Thailand, and Turkey.
Healthcare providers and facilities should stop using the affected lots and contact Boston Scientific for instructions on how to return the products. Consumers should not use these devices and should contact their healthcare provider if they have questions regarding their use.
The recalled product
- Product
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm UPN: M00536650
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 940
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 13 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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