Hobbs Biliary Pigtail Stent Kits Recalled for Incorrect Expiration Date Labels
Hobbs Medical is recalling Biliary Pigtail Stent Kits for incorrect expiration dates on product labels that may extend shelf life. Affected kits were distributed nationwide and internationally between March 2018 and 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 for a medical device with incorrect expiration date labeling. While no illnesses or injuries have been reported, the mislabeled expiration dates create a risk-of-harm scenario where expired biliary stents could be implanted, potentially compromising device sterility and effectiveness. This meets the rubric criterion for risk-of-harm products with unverified injury.
Plain-English summary
Hobbs Medical, Inc. is recalling Biliary Pigtail Stent Kits (Catalog Number 6024) because the product labels display incorrect expiration dates. The error extends the shelf life on the label, potentially allowing the use of expired devices.
The recall affects devices distributed from March 25, 2018 to September 28, 2020 in the United States and internationally (Canada, Austria, Belgium, Finland, and Norway). Affected products have lot numbers ending in R or are kits containing at least one device with a lot number ending in R. The affected labels show expiration dates between November 1, 2022 and September 1, 2025.
This is a Class II recall classified by the FDA. Individuals or facilities in possession of affected kits should contact Hobbs Medical, Inc. for further instructions regarding this recall.
The recalled product
- Product
- Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number: 6024
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device — Biliary Stent
- Hazard
- incorrect-expiration-date
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: M84960240 Lot Numbers: H02-19-023 H11-18-188
Distribution
Distributed nationwide across the United States.
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