Freeman Pancreatic Flexi-Stent Recalled for Incorrect Expiration Date
Hobbs Medical recalled Freeman Pancreatic Flexi-Stents due to incorrect expiration dates on device labels. The mislabeled dates extend shelf life, potentially allowing use of expired devices.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for incorrect expiration dating on a medical device that could allow use beyond intended shelf life. No illnesses or injuries reported, but the risk of device failure if used expired warrants High severity.
Plain-English summary
The Freeman Pancreatic Flexi-Stent (Catalog Number 6533), manufactured by Hobbs Medical, Inc., is being recalled due to incorrect expiration dates displayed on device labels.
The device labels display expiration dates that extend the shelf life of the product beyond its intended duration. This labeling error could result in the use of expired devices beyond their intended safe operating period.
The affected product was distributed in the United States nationwide and to Canada, Austria, Belgium, Finland, and Norway between March 25, 2018, and September 28, 2020. Affected devices are identified by lot numbers ending in 'R' or as kits containing at least one device with a lot number ending in 'R'. The expiration dates shown on the labels for affected units range from November 1, 2022, to September 1, 2025.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Catalog Number: 6533
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- expiration-dating-error
- labeling-error
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: M84965330 Lot Numbers: H08-17-085R
Distribution
Distributed nationwide across the United States.
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