Freeman Pancreatic Flexi-Stent Kit recalled for incorrect expiration date labeling
Hobbs Medical recalls the Freeman Pancreatic Flexi-Stent Kit due to incorrect expiration dates on product labels that extend shelf life. Affected devices were distributed to the US and international markets from March 2018 through 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 FDA Class II recall involves a medical device with incorrect expiration date labeling that extends shelf life. As a risk-of-harm product, this presents potential for harm through device degradation or malfunction in the absence of reported injuries.
Plain-English summary
The Freeman Pancreatic Flexi-Stent Kit is being recalled by Hobbs Medical, Inc. due to incorrect expiration dates displayed on product labels. The labels extend the shelf life beyond the intended period.
Affected products were distributed in the United States, Canada, Austria, Belgium, Finland, and Norway between March 25, 2018, and September 28, 2020. The recall applies to devices and kits with lot numbers ending in 'R' or kits containing at least one device with a lot number ending in 'R.' Affected products carry expiration dates ranging from November 1, 2022, to September 1, 2025.
Healthcare providers and individuals using affected Freeman Pancreatic Flexi-Stent Kits should contact Hobbs Medical, Inc. for instructions regarding product replacement and handling.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Kit (containing 6352) Catalog Number: 6321
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device — Stent
- Hazard
- mis-labeling
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:M84963210 Lot Numbers: H08-18-064 H08-18-116 H08-18-194
Distribution
Distributed nationwide across the United States.
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