Freeman Pancreatic Flexi-Stent Recall Due to Incorrect Expiration Date
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices due to incorrect expiration dates on product labels. The incorrect dates extend the shelf life, potentially allowing use beyond the actual safe expiration.
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 FDA recall of a medical device (pancreatic stent) where the labeling error creates a risk that devices may be used beyond their actual safe expiration. Although no illnesses or injuries have been reported, the product is a risk-of-harm device, meeting the criterion for high severity.
Plain-English summary
Hobbs Medical, Inc. is recalling Freeman Pancreatic Flexi-Stent (Catalog Number 6562, UDI-DI: M84965620) devices with lot numbers ending in R and kits containing at least one such device.
The device labels display an incorrect expiration date that extends the shelf life, meaning the labeled date is later than the actual safe expiration date.
The recall affects 30 units distributed in the United States nationwide and in Canada, Austria, Belgium, Finland, and Norway. The affected devices were distributed between March 25, 2018 and September 28, 2020 and bear expiration dates on the label between November 1, 2022 and September 1, 2025.
Healthcare providers and patients with affected devices should not use devices after their actual expiration date. Contact Hobbs Medical to determine the correct expiration date for your device and for further instructions.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Catalog Number: 6562
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- incorrect-expiration-date
- labeling-error
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: M84965620 Lot Numbers: H02-18-260R
Distribution
Distributed nationwide across the United States.
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