Medical Device Retrieval Basket Recalled for Incorrect Expiration Date
Hobbs Medical is recalling Helical Retrieval Baskets with incorrect expiration dates on labels. The labeled shelf life extends beyond the actual safe duration for device use.
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: This is an FDA Class II recall involving a labeling error with no reported injuries or illnesses. The incorrect expiration dates on device labels extend the shelf life representation beyond actual device safety limits, representing a documentation issue rather than a design or manufacturing defect.
Plain-English summary
Hobbs Medical, Inc. is recalling Hobbs Helical Retrieval Baskets (Catalog Number 4814) because product labels display incorrect expiration dates. The labeled expiration dates extend beyond the actual shelf life of the devices.
The recalled retrieval baskets were distributed from March 25, 2018 through September 28, 2020 in the United States, Canada, Austria, Belgium, Finland, and Norway. Affected devices have lot numbers ending in 'R' and display expiration dates ranging from November 1, 2022 through September 1, 2025.
Patients and healthcare facilities using these baskets should verify lot numbers to determine if they have affected devices. Devices with incorrect expiration dates may not perform safely if used beyond their actual shelf life. Contact Hobbs Medical, Inc. immediately with questions about replacing or returning recalled units.
The recalled product
- Product
- Hobbs Helical Retrieval Basket Catalog Number: 4814
- Manufacturer
- Hobbs Medical, Inc.
- Hazard
- incorrect-expiration-date
- labeling-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: M84948140 Lot Numbers: H10-17-098R
Distribution
Distributed nationwide across the United States.
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