Hobbs Biliary Pigtail Stent Kits recalled due to incorrect expiration date
Hobbs Medical is recalling Biliary Pigtail Stent Kits with incorrect expiration dates on labels. The incorrect dates extend the product shelf life, potentially allowing devices to be used past their actual expiration.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II labeling error with no reported illnesses, injuries, or adverse events. The incorrect expiration date extends the shelf life beyond the actual safe period, creating a theoretical risk of device use past its true expiration, consistent with Score 2 (Moderate) criteria.
Plain-English summary
Hobbs Medical, Inc. is recalling Biliary Pigtail Stent Kits (Catalog Number 6004, UDI-DI: M84960040) because the device labels display an incorrect expiration date that extends the shelf life of the product.
Affected units were distributed in the United States from March 25, 2018 to September 28, 2020. The recalled devices have lot number H02-19-022 with lot numbers ending in 'R', or are kits containing at least one device with such a lot number. The labels on these affected devices show expiration dates between November 1, 2022 and September 1, 2025. The product has also been distributed worldwide to Canada, Austria, Belgium, Finland, and Norway.
The incorrect expiration dates on the labels could result in devices being stored or used beyond their actual safe shelf life. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Hobbs Biliary Pigtail Stent Kits (containing 3412) Catalog Number:6004
- Manufacturer
- Hobbs Medical, Inc.
- 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: M84960040 Lot Numbers: H02-19-022
Distribution
Distributed nationwide across the United States.
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