Hobbs Biliary Pigtail Stent Kits recalled for incorrect expiration date
Hobbs Medical recalls biliary stent kits with incorrect expiration dates that extend shelf life. The kits were distributed from 2018 to 2020 in the US and select countries.
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 (biliary stent) with an incorrect expiration date. Although no illnesses or injuries have been reported, the use of an expired medical device constitutes a risk-of-harm product, meeting the High severity criterion.
Plain-English summary
Hobbs Medical, Inc. is recalling Biliary Pigtail Stent Kits (Catalog Number 6023) because the device labels display an incorrect expiration date that extends the shelf life of the product.
The affected stent kits were distributed worldwide, including the United States and the countries of Canada, Austria, Belgium, Finland, and Norway. The kits were distributed from March 25, 2018 to September 28, 2020. Affected devices include those with lot numbers ending in "R" or kits containing at least one device with a lot number ending in "R." The recalled units have expiration dates between November 1, 2022 and September 1, 2025.
The recall is being conducted because the incorrect expiration date on the device label allows the product to be used beyond its actual shelf life, which could compromise the safety and effectiveness of the medical device.
The recalled product
- Product
- Hobbs Biliary Pigtail Stent Kits (containing 6105) Catalog Number: 6023
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device — Biliary Stent
- Hazard
- mis-labeling
- expiration-date-error
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: M84960230 Lot Numbers: H02-19-019 H10-18-183
Distribution
Distributed nationwide across the United States.
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