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.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving medical devices where the defect could lead to adverse health consequences.
Plain-English summary
AngioDynamics, Inc. is recalling Uni*Fuse Infusion Systems with Cooper Wire, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085. The recall is limited to Lot 4731641 with an expiration date of 31-Mar-17.
The company identified that these infusion systems have the potential to contain an incorrect sized guidewire that is too long. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
A total of 94 units were distributed, consisting of 81 units in the United States and 13 units internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland. Healthcare providers and patients should contact AngioDynamics for further instructions regarding the return or replacement of these devices.
The recalled product
- Product
- Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H787124018085, 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 4731641 (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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