Recall Z-2260-2014
Angiodynamics, Inc. · initiated August 6, 2014
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: Lot 4731639 (exp. date 31-Mar-17)
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).
FDA-determined cause: Component design/selection
Action taken
AngioDynamics sent an URGENT MEDICAL DEVICE RECALL Letter dated August 6, 2014, to all affected customers via Federal Express. Consignees were instructed to segregate and return all affected devices to AngioDynamics, Inc. and complete and return the Reply Verification Tracking Form, provided in the recall notification. Those customers with the affected product were also instructed to call AngioDynamics Customer Service at 1-800-772-6446. For questions regarding this recall call 718-742-4571.
Details
- Recall number
- Z-2260-2014
- Initiated
- August 6, 2014
- Posted by FDA
- August 18, 2014
- Terminated
- March 27, 2017
- Product code
- KRA – Catheter, Continuous Flush
- Quantity
- Domestic: 70 units; Foreign: 27 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland.
- Recalling firm
- Angiodynamics, Inc., Queensbury, NY
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2261-2014 Class II | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog…AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an… | 08/06/2014Terminated |
| Z-2262-2014 Class II | Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 40 cm Infusion Pattern, Catalog…AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an… | 08/06/2014Terminated |