Freeman Pancreatic Flexi-Stent Kit: Incorrect Expiration Date on Device Labels
Hobbs Medical recalls Freeman Pancreatic Flexi-Stent Kits with incorrect expiration dates on labels that may extend shelf life beyond the actual expiration date.
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: FDA Class II medical device with a labeling defect that could result in use of expired stents. While no injuries have been reported, incorrect expiration dating on critical surgical devices poses a significant risk of harm if expired devices are used during patient care.
Plain-English summary
Hobbs Medical, Inc. is recalling Freeman Pancreatic Flexi-Stent Kits (Catalog Number 6529) due to incorrect expiration dates displayed on device labels.
The device labels display an incorrect expiration date that extends the apparent shelf life of the product. Affected devices have lot numbers ending in R, or are kits containing at least one device with a lot number ending in R. This labeling error could result in use of expired devices, which may not maintain their intended safety and performance characteristics.
The affected products were distributed worldwide, including the United States, Canada, Austria, Belgium, Finland, and Norway. In the United States, affected products were distributed from March 25, 2018 to September 28, 2020. The affected lot numbers include H08-18-117 and H08-18-192, with affected expiration dates ranging from November 1, 2022 to September 1, 2025.
Patients and healthcare providers should verify the actual expiration date of Freeman Pancreatic Flexi-Stent Kits. Contact Hobbs Medical, Inc. or your device distributor for guidance regarding the authenticity and safety of affected devices.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Kit (containing 6568) Catalog Number: 6529
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- mis-labeling
- expired-device
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: M84965290 Lot Numbers: H08-18-117 H08-18-192
Distribution
Distributed nationwide across the United States.
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