Freeman Pancreatic Flexi-Stent Kits Recalled Due to Incorrect Expiration Dates
Freeman Pancreatic Flexi-Stent Kits are recalled due to device labels displaying incorrect expiration dates that extend shelf life. Affected units were distributed in the US and select countries from March 2018 to September 2020.
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 an FDA Class II recall of a medical device with no reported hospitalizations or injuries. The hazard represents a risk-of-harm product where injury has not yet been reported, as use beyond intended shelf life could compromise device integrity in a clinical setting.
Plain-English summary
Freeman Pancreatic Flexi-Stent Kits (Catalog Number 6503) manufactured by Hobbs Medical, Inc. are the subject of this recall due to a labeling issue.
The device labels display an incorrect expiration date that extends the shelf life of the product. This means devices may be labeled with an expiration date later than their actual intended shelf life.
Affected products were distributed worldwide to the United States and Canada, Austria, Belgium, Finland, and Norway. In the United States, distribution occurred between March 25, 2018 and September 28, 2020. Affected units have expiration dates between November 1, 2022 and September 1, 2025. Devices can be identified by lot numbers ending in R, or are contained in kits with at least one device having a lot number ending in R. The affected lot numbers include H05-20-155 and H06-20-022 (UDI-DI: M84965030).
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Kits: Single Pigtail (containing 6544) Catalog Number: 6503
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- incorrect-expiration-dating
- device-degradation-risk
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: M84965030 Lot Numbers: H05-20-155 H06-20-022
Distribution
Distributed nationwide across the United States.
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