Freeman Pancreatic Flexi-Stent Kit Recalled for Mislabeled Expiration Date
Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kit units with incorrect expiration dates on labels, extending apparent shelf life. Units distributed in the US and Canada, Austria, Belgium, Finland, and Norway from 2018–2020 are affected.
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: This is a risk-of-harm medical device (pancreatic stent) where incorrect expiration dating creates potential for use of expired or compromised devices. No hospitalizations or injuries have been reported per the source text, placing this at Score 3 per the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Hobbs Medical, Inc. is recalling Freeman Pancreatic Flexi-Stent Kit (Catalog Number 6507) because device labels display an incorrect expiration date, extending the apparent shelf life beyond the actual shelf life.
Affected units were distributed from March 25, 2018, through September 28, 2020, to the United States and internationally to Canada, Austria, Belgium, Finland, and Norway. The recall includes all units with lot numbers ending in R, or kits containing at least one device with a lot number ending in R. These devices have expiration dates between November 1, 2022, and September 1, 2025.
Healthcare providers and patients should verify lot numbers and expiration dates on Freeman Pancreatic Flexi-Stent Kit units to identify affected devices. Lot numbers ending in R indicate affected products. Anyone with affected units should contact Hobbs Medical, Inc., the manufacturer.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Kit (containing 6533) Catalog Number: 6507
- 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: M84965070 Lot Numbers: H08-18-075
Distribution
Distributed nationwide across the United States.
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