FDAFDA · Food and drugs·Recall number Z-2261-2014
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
Published August 27, 2014 · Recall initiated: August 6, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Angiodynamics, Inc.
- Distributor
- Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland.
- Lot
- Lot 4731641 (exp. date 31-Mar-17)
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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