Recall Z-3267-2011 ยท KRA Catheter, Continuous Flush
Angiodynamics Worldwide Headquarters
ANGIODYNAMICS UNI*FUSE INFUSION SYSTEM WITH COOPER WIRE, Catalog No./REF 12401819, CATHETER SIZE 4F, CATHETER LENGTH 90 cm, INFUSION LENGTH 20 cm, OCCLUSION WIRE SIZE .035 in., STERILE, AngioDynamics Inc., 603 Queensbury Avenue, Queensbury, NY 12804
| Date | Sep 19, 2011 (initiated Jan 28, 2011) |
| Status | Terminated |
| Reason | The particular lots of UniFuse Catheters were packaged with the wrong occluding ball guidewires. |
| Root cause | Employee error |
| Action | URGENT MEDICAL DEVICE RECALL LETTERS (dated 1/28/11) and Recall Reply Forms were sent to the consignees via Certified Mail, Return Receipt Requested. The letters identified the scope of the recall, the reason for the recall, the status, and action to be taken. Customers were to identify and segregate the recalled lot in their possession. They were also to complete and fax back the Reply Form. The recalled product should be returned along with a copy of the Reply Form. Replacement product would be shipped upon receipt and confirmation of the returned product. Questions or concerns should |
| Quantity | 24 units |
| Distribution | Worldwide Distribution -- USA and The Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K951509 | PULSE*SPRAY INFUSION SYSTEM Angiodynamics, Div. E-Z-Em, Inc., Jun 16, 1995 |