Freeman Pancreatic Flexi-Stent Recall Due to Incorrect Expiration Dates
Hobbs Medical recalled Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on labels that extend the shelf life, potentially allowing use beyond intended timeframe.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 medical device recall where incorrect expiration dating extends shelf life, creating a risk-of-harm situation if devices are used beyond their true expiration date.
Plain-English summary
Hobbs Medical, Inc. is recalling Freeman Pancreatic Flexi-Stent devices (Catalog Number 6566) due to incorrect expiration dates on device labels. The labeling error extends the shelf life, potentially allowing use of devices beyond their intended expiration period.
Affected devices were distributed in the United States from March 25, 2018, through September 28, 2020. Specifically, devices with lot numbers ending in "R" or kits containing at least one device with a lot number ending in "R" are affected. The incorrect expiration dates on affected labels range from November 1, 2022, to September 1, 2025. The product was also distributed internationally to Canada, Austria, Belgium, Finland, and Norway.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Catalog Number: 6566
- Manufacturer
- Hobbs Medical, Inc.
- Affected units
- 8
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: M84965660 Lot Numbers: H01-18-204R
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 61 recalled by Hobbs Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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