Hobbs Medical Polypectomy Snare with Incorrect Expiration Date Label
Hobbs Medical is recalling Polypectomy Snares (Catalog 7202) with incorrect expiration dates on labels, which could allow use of expired devices. Units were distributed in the US and several other countries 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 Class II FDA recall of a medical device with a labeling defect. Although no injuries or illnesses have been reported, using an expired medical device in endoscopic procedures presents a genuine risk of harm. The hazard is theoretical but significant given the device's intended use in surgical settings.
Plain-English summary
Hobbs Medical, Inc. is recalling Polypectomy Snare Catalog Number 7202. The device labels display an incorrect expiration date, which extends the stated shelf life of the product. This could result in devices being used beyond their actual safe operational period.
The affected devices were distributed from March 25, 2018, to September 28, 2020. These are devices with lot numbers ending in 'R' (including H10-17-089R and H08-17-014R) or kits containing at least one device with a lot number ending in 'R.' The devices were distributed in the United States and in Canada, Austria, Belgium, Finland, and Norway. These devices carry labels with incorrect expiration dates ranging from November 1, 2022, to September 1, 2025.
Healthcare facilities and individuals with affected devices should verify whether their Polypectomy Snares have lot numbers ending in 'R.' Affected devices should not be used due to the potential for use beyond the actual safe expiration date. Contact Hobbs Medical, Inc. for instructions on proper handling of the recalled devices.
The recalled product
- Product
- Hobbs Medical Polypectomy Snare Catalog Number: 7202
- Manufacturer
- Hobbs Medical, Inc.
- Affected units
- 20
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: M84972020 Lot Numbers: H10-17-089R H08-17-014R
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 61 recalled by Hobbs Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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