Pancreatic stent recall due to incorrect expiration date on device labels
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices distributed between March 2018 and September 2020 due to incorrect expiration dates on product labels. The mislabeled devices display extended shelf-life information that does not reflect actual product safety.
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: FDA Class II recall involving a labeling error on a medical device with an extended expiration date on the label. No illnesses, injuries, or deaths have been reported, making this a minor labeling error with theoretical risk only.
Plain-English summary
Hobbs Medical, Inc. is recalling the Freeman Pancreatic Flexi-Stent (Catalog Number 6568), a medical device used in pancreatic procedures. The recall affects devices with lot numbers ending in "R" or kits containing at least one device with such a lot number.
The device labels display an incorrect expiration date that extends the product's shelf life beyond its actual safety period. Affected products were distributed in the United States between March 25, 2018, and September 28, 2020, with incorrect expiration dates on labels ranging from November 1, 2022, to September 1, 2025.
The recalled devices were distributed worldwide to the United States and the countries of Canada, Austria, Belgium, Finland, and Norway. Affected devices have lot numbers ending in "R" or are kits containing at least one device with such a lot number.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Catalog Number: 6568
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- mis-labeling
- expired-device
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)
- UDI-DI: M84965680 Lot Numbers: H12-17-203R
Distribution
Distributed nationwide across the United States.
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