Uni*Fuse INFUSION SYSTEM WITH COOPER WIRE, 5F x 90 cm x 30 cm Infusion Pattern, Catalog No./REF 12401808, Product No. H7
FDA device recall Z-2261-2014 · posted 2014-08-18 · Terminated
Recall details
- Recalling firm
- Angiodynamics, Inc.
- 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).
- 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.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- KRA
- Quantity affected
- Domestic: 81 units; Foreign: 13 units
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to Austria, Australia, Ireland, Malaysia, Sweden, and Switzerland.
- Date initiated
- 2014-08-06
- Date posted
- 2014-08-18
- Date terminated
- 2017-03-27
- Location
- Queensbury, NY
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PULSE*SPRAY INFUSION SYSTEM (K961763) | Angiodynamics, Div. E-Z-Em, Inc. | 1996-07-17 |
| PULSE*SPRAY INFUSION SYSTEM (K951602) | Angiodynamics, Div. E-Z-Em, Inc. | 1995-06-14 |
| E-Z-EM PULSED INFUSION SYSTEM (K905447) | E-Z-Em, Inc. | 1991-04-01 |