Freeman Pancreatic Flexi-Stent Medical Device Recalled for Mislabeled Expiration Date
Hobbs Medical recalls Freeman Pancreatic Flexi-Stent devices with incorrect expiration dates that extend shelf life, affecting devices distributed in the US and five other countries from 2018 to 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 a Class II medical device recall involving mislabeled expiration dates on a pancreatic stent. Although no injuries or illnesses have been reported, using an expired medical device presents a risk of harm. Per the rubric, risk-of-harm products where injury has not yet been reported score as High (3).
Plain-English summary
Hobbs Medical, Inc. is recalling Freeman Pancreatic Flexi-Stent medical devices (Catalog Number 6534) because the device labels display incorrect expiration dates.
The labels show expiration dates that extend beyond the actual product shelf life. The affected devices have lot numbers ending in 'R' or are kits containing at least one device with a lot number ending in 'R'. These devices were distributed between March 25, 2018 and September 28, 2020, with mislabeled expiration dates ranging from November 1, 2022 to September 1, 2025.
The affected devices were distributed worldwide, including in the United States, Canada, Austria, Belgium, Finland, and Norway. No injuries or illnesses have been reported. Facilities and providers should verify product lot numbers and ensure affected devices are not used.
The recalled product
- Product
- Freeman Pancreatic Flexi-Stent Catalog Number: 6534
- Manufacturer
- Hobbs Medical, Inc.
- Affected units
- 10
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: M84965340 Lot Numbers: H11-17-025R
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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