AngioDynamics Recalls Soft-Vu Omni Flush Angiographic Catheters
AngioDynamics is recalling 28 Soft-Vu Omni Flush Angiographic Catheters because they were distributed before required post-sterilization release activities were completed.
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 3/5 (High).
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: The recall involves a medical device distributed before required sterilization release activities were completed, creating a risk of harm (infection) that has not yet been reported as an injury or illness.
Plain-English summary
AngioDynamics, Inc. is recalling 28 units of the Soft-Vu Omni Flush Angiographic Catheter (Catalog Number: 10732201). The specific lot number is 5229642, manufactured on September 6, 2017, with an expiration date of August 31, 2020.
The recall was initiated because the product was placed into distribution prior to the completion of all required post-sterilization release activities. This procedural deviation means the catheters may not have undergone the final quality checks required to ensure they are sterile and safe for use.
The affected units were distributed in the United States to the states of Alabama, California, Connecticut, Florida, Georgia, Illinois, Indiana, Maryland, Michigan, Minnesota, Missouri, Ohio, Oregon, and Texas. Healthcare facilities and distributors should stop using these specific catheters and contact AngioDynamics for instructions on return or disposal.
The recalled product
- Product
- Soft-Vu Omni Flush Angiographic Catheter (UPN H787107322015); SV OF 5F x 65 cm .035 NB PG; Catalog Number: 10732201 AngioDynamics Angiographic Catheters are for use where angiographic diagnosis is indicated.
- Manufacturer
- Angiodynamics, Inc.
- Affected units
- 28
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 (3)
- Lot Number: 5229642
- Manufactured 6-Sep-17
- Expiration Date: 31-Aug-20
Distribution
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