Freeman Pancreatic Flexi-Stent labeled with incorrect expiration dates
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stents with incorrect expiration dates on device labels that extend shelf life. Devices were distributed in the US and internationally from March 2018 to September 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 involving a mislabeling of expiration dates that presents a risk of harm—sterile devices used beyond their actual shelf life could lose sterility and compromise safety. While no illnesses or injuries have been reported, the product poses a risk of harm if used as labeled.
Plain-English summary
Hobbs Medical, Inc. is recalling Freeman Pancreatic Flexi-Stents (Catalog Number 6548) due to incorrect expiration dates displayed on device labels. The incorrect expiration date extends the shelf life shown on the product label.
Affected devices were distributed in the United States, Canada, Austria, Belgium, Finland, and Norway between March 25, 2018 and September 28, 2020. Devices with lot numbers ending in R, or kits containing at least one device with a lot number ending in R are affected. The specific lot number involved is H06-17-182R.
The incorrect expiration date on the device label could result in use of the device beyond its actual intended shelf life, which may compromise the device's sterility and safety. If you have received this product, contact Hobbs Medical for instructions regarding its return or replacement.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Catalog Number: 6548
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- mislabeling
- incorrect-expiration
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: M84965480 Lot Numbers: H06-17-182R
Distribution
Distributed nationwide across the United States.
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