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
Reported: August 27, 2014 Initiated: August 6, 2014 #Z-2261-2014
Product Description
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
Reason for Recall
AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
Details
- Recalling Firm
- Angiodynamics, Inc.
- Units Affected
- Domestic: 81 units; Foreign: 13 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland.
- Location
- Queensbury, NY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Angiodynamics, Inc.. Units affected: Domestic: 81 units; Foreign: 13 units.
Why was this product recalled? ▼
AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 27, 2014. Severity: Moderate. Recall number: Z-2261-2014.
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