Hobbs Helical Retrieval Basket Recall Due to Incorrect Expiration Date Label
Hobbs Medical is recalling Hobbs Helical Retrieval Basket (Catalog Number 4830) due to an incorrect expiration date on the device label. Affected devices have lot numbers ending in 'R' and were distributed in the US from March 2018 to 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 a risk-of-harm medical device recall where expired devices could be used in patient procedures, but no injuries or illnesses have been reported. FDA Class II classification with labeling error as the primary defect.
Plain-English summary
Hobbs Medical, Inc. is recalling the Hobbs Helical Retrieval Basket (Catalog Number 4830) due to an incorrect expiration date printed on the device label. Affected devices have lot numbers ending in 'R'.
The mislabeled expiration date extends the shelf life of the product, which means devices could be used beyond their true expiration date. Affected devices were distributed in the United States from March 25, 2018 to September 28, 2020. The incorrect expiration dates on the labels range from November 1, 2022 to September 1, 2025.
Consumers who have this product should contact Hobbs Medical, Inc. for instructions on verifying the true expiration date and proper handling of the device. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- Hobbs Helical Retrieval Basket Catalog Number: 4830
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device
- Hazard
- expiration-date-mislabeling
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: M84948300 Lot Numbers: H10-16-021R
Distribution
Distributed nationwide across the United States.
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