AngioDynamics VenaCure EVLT NeverTouch Procedure Kit Recalled for RFID Error
AngioDynamics is recalling VenaCure EVLT NeverTouch Procedure Kits because an RFID programming error prevents the product from being used with the laser source.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low because the defect is a documentation/programming error that prevents the product from being used, posing no risk of adverse health consequences or injury.
Plain-English summary
AngioDynamics, Inc. is recalling 109 units of the VenaCure EVLT NeverTouch Procedure Kit, Catalog Number 11403012. The affected products are identified by Lot 5456490 and UPN H787114030120. The recall was initiated because the RFID programmed expiration date is incorrectly set to April 2014, despite the product being properly labeled with an expiration date of March 31, 2022.
This RFID discrepancy results in an error message when the product is connected to the laser source, which prevents the product from being used. The affected products were distributed to the following US states: DC, IL, IN, MI, NJ, TN, TX, and WI.
Healthcare providers and facilities should stop using the affected procedure kits and contact AngioDynamics for further instructions.
The recalled product
- Product
- AngioDynamics VenaCure EVLT NeverTouch Procedure Kit, 45CM NEVERTOUCH FRS .018 PROCEDURE KIT PG, Catalog Number 11403012
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device — Surgical Kits
- Hazard
- Affected units
- 109
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 (2)
- Lot 5456490
- UPN H787114030120
Distribution
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