AngioDynamics Recalls Uni*Fuse Infusion Systems Due to Potential Guidewire Size Error
AngioDynamics is recalling Uni*Fuse Infusion Systems with Cooper Wire because they may contain a guidewire that is too long.
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 is classified as FDA Class II, and the source describes a potential defect in a medical device without reporting specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
AngioDynamics, Inc. is recalling Uni*Fuse Infusion Systems with Cooper Wire, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065. The recall involves Lot 4731639 with an expiration date of 31-Mar-17.
The company determined that the affected infusion systems have the potential to contain an incorrectly sized guidewire that is too long. This defect could potentially affect the safety or efficacy of the medical device during use.
The recall covers 70 units distributed domestically in the United States and 27 units distributed internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland. Healthcare providers and facilities that have received these specific units should stop using them and contact AngioDynamics for instructions on return or replacement.
The recalled product
- Product
- Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 10 cm Infusion Pattern, Catalog No./REF 12401806, Product No. H787124018065, STERILE -- AngioDynamics, 603 Queensbury Avenue, Queensbury, NY 12804
- Manufacturer
- Angiodynamics, Inc.
- Category
- Medical Device — Infusion System
- Hazard
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)
- Lot 4731639 (exp. date 31-Mar-17)
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Angiodynamics, 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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