Boston Scientific Recalls Pancreatic Stents Due to Incorrect Shelf Life Labeling
Boston Scientific is recalling 97 Advanix Pancreatic Stents because they were 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, but the source text identifies the issue as a labeling error regarding shelf life without reporting any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Boston Scientific Corporation is recalling 97 units of the Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm (UPN: M00536660). The recall involves specific lot numbers: 21312747, 21865108, 22275742, and 24411527. These products were manufactured between September 29, 2017, and September 12, 2019.
The recall was initiated because the affected units were labeled with a 36-month shelf life, whereas the approved shelf life for these devices is 18 months. This labeling error may lead to the use of devices beyond their validated expiration dates.
The products were distributed nationwide and in several 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 return or replacement.
The recalled product
- Product
- Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm UPN: M00536660
- Manufacturer
- Boston Scientific Corporation
- Hazard
- Affected units
- 97
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 Numbers: 21312747 21865108 22275742 24411527
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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