Freeman Pancreatic Flexi-Stent Kits Recalled for Incorrect Expiration Dates
Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kits due to labeling errors showing incorrect expiration dates that extend the shelf life of affected 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: This is a risk-of-harm product (critical pancreatic stent) where injury has not yet been reported. Using devices past their actual expiration date could result in device degradation or failure.
Plain-English summary
Hobbs Medical, Inc. has recalled Freeman Pancreatic Flexi-Stent Kits due to labeling errors that display incorrect expiration dates. The affected devices show expiration dates that extend the shelf life beyond the actual product expiration date.
Affected products were distributed in the United States from March 25, 2018 through September 28, 2020. The affected devices have lot numbers ending in R, or are kits containing at least one device with a lot number ending in R. Specific lot numbers include H08-18-119 and H08-18-191. The affected labels display expiration dates between November 1, 2022 and September 1, 2025.
Healthcare providers with affected devices should discontinue use and contact Hobbs Medical, Inc. for replacement. Facilities should verify affected inventory against lot numbers H08-18-119 and H08-18-191 before using any pancreatic stents.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Kit (containing 6567) Catalog Number: 6519
- Manufacturer
- Hobbs Medical, Inc.
- 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: M84965190 Lot Numbers: H08-18-119 H08-18-191
Distribution
Distributed nationwide across the United States.
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