Freeman Pancreatic Flexi-Stent Kits recalled for incorrect expiration dates
Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kits due to mislabeled expiration dates that may extend shelf life. Affected devices with lot numbers ending in R were distributed in the US and internationally from 2018-2020.
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 Class II medical device recall for mislabeled expiration dates. While no illnesses or injuries have been reported, using expired pancreatic stents could compromise device sterility and functionality. Per the rubric, Class II recalls without reported hospitalization are capped at score 3.
Plain-English summary
Hobbs Medical, Inc. is recalling Freeman Pancreatic Flexi-Stent Kits (Single Pigtail, Catalog Number 6501) because device labels display incorrect expiration dates. The mislabeled dates effectively extend the shelf life of the products, potentially resulting in use of expired devices.
Affected products were distributed in the United States from March 25, 2018 to September 28, 2020, and internationally in Canada, Austria, Belgium, Finland, and Norway. The recall applies to lot H09-18-008 where individual devices bear lot numbers ending in R, or to kits containing at least one such device. These affected products have printed expiration dates ranging from November 1, 2022 to September 1, 2025.
Healthcare providers who have received these products should identify and quarantine any affected devices and contact Hobbs Medical for guidance. Use of an expired pancreatic stent could compromise the device's sterility and functionality. Patients should contact their healthcare provider with any questions about their treatment or if they received one of these devices.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Kits: Single Pigtail Catalog Number: 6501
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- mislabeled-expiration
- sterility-risk
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: M84965010 Lot Numbers: H09-18-008
Distribution
Distributed nationwide across the United States.
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