Freeman Pancreatic Flexi-Stent Distributed with Incorrect Expiration Date
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on the device labels. Affected units distributed in the US and internationally from March 2018 to September 2020 may have been used beyond their actual safe shelf life.
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: The recall involves an FDA Class II medical device with a labeling defect where the expiration date is incorrect and extends the shelf life beyond the device's actual safe use period. No illnesses or injuries have been reported, but the use of expired medical devices in critical procedures presents a potential risk of harm, qualifying this as a risk-of-harm product recall.
Plain-English summary
Hobbs Medical, Inc. is recalling Freeman Pancreatic Flexi-Stent (Catalog Number 6544) devices distributed in the United States and internationally. The device labels display an incorrect expiration date that extends the shelf life of the product.
Affected devices include those with lot numbers ending in 'R', or kits containing at least one device with a lot number ending in 'R'. A total of 27 units were distributed between March 25, 2018 and September 28, 2020, with label expiration dates between November 1, 2022 and September 1, 2025. The devices were distributed to the US and the countries of Canada, Austria, Belgium, Finland, and Norway.
Facilities and healthcare providers who have received affected Freeman Pancreatic Flexi-Stent units should discontinue their use and contact Hobbs Medical regarding the recall.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Catalog Number: 6544
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device — Stent
- Hazard
- expiration-date-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: 84965410 Lot Numbers: H01-20-254R
Distribution
Distributed nationwide across the United States.
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