Hobbs Biliary Pigtail Stent Kits Recalled for Incorrect Expiration Dates
Hobbs Medical is recalling Biliary Pigtail Stent Kits due to incorrect expiration dates on device labels that extend shelf life, affecting 15 units distributed 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 used in critical biliary procedures. While no illnesses or injuries have been reported, expired stents could malfunction or fail during use, creating a significant risk of patient harm. The incorrect expiration labeling extends shelf life, potentially allowing use of devices beyond safe functionality.
Plain-English summary
Hobbs Medical, Inc. is recalling Biliary Pigtail Stent Kits (Catalog Number 6104, UDI-DI: M84961040) for labeling defects. Device labels display incorrect expiration dates that extend the shelf life of the product, potentially allowing use of devices beyond their intended viability.
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 carry expiration dates on their labels between November 1, 2022 and September 1, 2025. The affected products were distributed in the United States and internationally (Canada, Austria, Belgium, Finland, Norway) from March 25, 2018 to September 28, 2020. A total of 15 units were involved in this recall.
The recalled product
- Product
- Hobbs Biliary Pigtail Stent Kits Catalog Number: 6104
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device — Biliary Stent
- Hazard
- expiration-mislabeling
- shelf-life-extension
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: M84961040 Lot Numbers: H11-17-020R
Distribution
Distributed nationwide across the United States.
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