Hobbs Medical Polypectomy Snare with Incorrect Expiration Date Label
Hobbs Medical is recalling Polypectomy Snare model 4565-OLY due to incorrect expiration dates on device labels that extend the product's shelf life. Affected devices were distributed between March 2018 and 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: FDA Class II medical device recall for incorrect expiration date labeling that extends the product's shelf life. This is a risk-of-harm scenario where devices may be used beyond their intended shelf life, potentially compromising device sterility and function, though no injuries or illnesses have been reported.
Plain-English summary
Hobbs Medical, Inc. is recalling Polypectomy Snare model 4565-OLY due to incorrect expiration dates displayed on device labels. The label error extends the shelf life of the product, which could result in the use of devices beyond their intended lifespan.
The affected devices were distributed worldwide, including the United States, Canada, Austria, Belgium, Finland, and Norway, between March 25, 2018 and September 28, 2020. Affected expiration dates on the labels range from November 1, 2022 to September 1, 2025. Devices with lot numbers ending in "R" or kits containing at least one device with a lot number ending in "R" are included in this recall.
Patients and healthcare providers should immediately discontinue use of affected devices and contact Hobbs Medical, Inc. for guidance on proper device disposal and replacement.
The recalled product
- Product
- Hobbs Medical Polypectomy Snare Catalog Number: 4565-OLY
- Manufacturer
- Hobbs Medical, Inc.
- Category
- Medical Device
- Hazard
- incorrect-expiration
- shelf-life-extension
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: M8494565OLY0 Lot Numbers: H02-18-111R H04-18-063R
Distribution
Distributed nationwide across the United States.
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