Freeman Pancreatic Flexi-Stent Kit Recalled for Mislabeled Expiration Dates
Hobbs Medical recalls Freeman Pancreatic Flexi-Stent kits with incorrect expiration dates on the label, which extends the stated shelf life and could allow 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 of a high-risk medical device with mislabeled expiration dates that extend stated shelf life, creating direct risk of use of expired devices. No illnesses or injuries reported, but the hazard to patient safety is genuine and not theoretical.
Plain-English summary
Freeman Pancreatic Flexi-Stent kits (Catalog Number 6518), manufactured by Hobbs Medical, Inc., are being recalled due to incorrect expiration dates printed on the device labels. The labeling error extends the stated shelf life of the products, potentially allowing use of expired devices.
The affected products were distributed from March 25, 2018 to September 28, 2020 in the United States, Canada, Austria, Belgium, Finland, and Norway. The recalled kits have expiration dates shown between November 1, 2022 and September 1, 2025, and contain lot numbers ending in R (Lot Numbers H08-18-118 and H08-18-212).
Healthcare providers and patients who have received these kits should verify the actual expiration date with the manufacturer and avoid using any devices that may have exceeded their true shelf life. Contact Hobbs Medical, Inc. for guidance on verifying the actual expiration date or obtaining replacement units.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Kit (containing 6566) Catalog Number: 6518
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device — Stent
- Hazard
- mislabeled-expiration
- 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: M84965180 Lot Numbers: H08-18-118 H08-18-212
Distribution
Distributed nationwide across the United States.
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