Medical device retrieval basket labels show incorrect expiration dates
Hobbs Medical recalls the Helical Retrieval Basket due to labels displaying incorrect expiration dates that extend the device's shelf life. Affected units distributed worldwide from March 2018 to September 2020 may be used beyond their validated lifespan.
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: FDA Class II device with expiration date mislabeling that extends the shelf life, creating risk of device use beyond its validated lifespan. No illnesses or injuries have been reported, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
The Hobbs Helical Retrieval Basket (Catalog Number 4806), manufactured by Hobbs Medical, Inc., is being recalled because device labels display incorrect expiration dates that extend the product's shelf life beyond its actual validated timeframe.
The incorrect expiration dates on device labels could result in retrieval baskets being used beyond their actual validated shelf life. Using devices beyond their validated expiration may compromise device performance or sterility and pose a risk to patient safety.
Affected devices were distributed worldwide from March 25, 2018, through September 28, 2020, to the United States, Canada, Austria, Belgium, Finland, and Norway. The recall applies to devices with lot numbers ending in 'R' or kits containing at least one device with a lot number ending in 'R', with expiration dates ranging from November 1, 2022, to September 1, 2025 (UDI-DI: M84948060).
Healthcare facilities and providers using this device should stop using affected units and contact Hobbs Medical, Inc., for device replacement or further recall information.
The recalled product
- Product
- Hobbs Helical Retrieval Basket Catalog Number: 4806
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device
- Hazard
- 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: M84948060 Lot Numbers: H02-18-112R
Distribution
Distributed nationwide across the United States.
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