Freeman Pancreatic Flexi-Stent Recall Due to Incorrect Expiration Date Label
Hobbs Medical is recalling Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates on labels. Affected units distributed in the US and internationally from 2018 to 2020 may have extended shelf lives beyond accuracy.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a Class II recall with a labeling error affecting expiration dates. No illnesses or injuries have been reported, and the hazard is theoretical; therefore this recall is scored as Moderate per the rubric for minor labeling errors on precautionary recalls.
Plain-English summary
Hobbs Medical, Inc. is recalling Freeman Pancreatic Flexi-Stent devices (Catalog Number 6535) due to incorrect expiration dates displayed on device labels. The labeling error extends the shelf life of the product beyond the accurate expiration, which could compromise device integrity if used beyond the actual expiration date.
This recall affects 13 units that were distributed worldwide, including the United States, Canada, Austria, Belgium, Finland, and Norway. The affected devices were distributed between March 25, 2018 and September 28, 2020. Affected units have expiration dates ranging from November 1, 2022 to September 1, 2025 and can be identified by lot numbers ending in "R" or kits containing at least one device with a lot number ending in "R" (Lot Number: H01-16-055R).
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Catalog Number: 6535
- Manufacturer
- Hobbs Medical, Inc.
- Affected units
- 13
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: M84965350 Lot Numbers: H01-16-055R
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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