Boston Scientific Recalls Pancreatic Stents with Incorrect Shelf Life Labeling
Boston Scientific is recalling Advanix Pancreatic Stents labeled with a 36-month shelf life instead of the approved 18-month duration.
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 hazard is a labeling error regarding shelf life, which is a moderate risk compared to direct contamination or structural failure.
Plain-English summary
Boston Scientific Corporation is recalling 222 units of Advanix Pancreatic Stents, Straight Leading Barb, 10F x 10cm (UPN: M005336680). The affected units were manufactured between September 29, 2017, and September 12, 2019, and are associated with specific lot numbers including 21285272, 21568464, 21750673, 21865109, 22072355, 22613957, 23408730, and 23492662.
The recall was initiated because the products were labeled with a 36-month shelf life rather than the approved 18-month shelf life. This labeling error may result in the use of the device beyond its validated expiration date.
The affected devices were distributed nationwide and to 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 check their inventory for these specific lot numbers and stop using the affected devices.
The recalled product
- Product
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm UPN: M005336680
- Manufacturer
- Boston Scientific Corporation
- Affected units
- 222
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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