Recall Z-1733-2010 ยท KRA Catheter, Continuous Flush
Angiodynamics, Inc.
ANGIODYNAMICS BENEPHIT(TM) XT Infusion System, 35 cm, Targeted Renal Therapy Infusion system, Model/REF Number 70035, STERILE, EO, Intended for Single Use Only. AngioDynamics, Incorporated 603 Queensbury, NY 12804.
| Date | May 28, 2010 (initiated Apr 30, 2010) |
| Status | Terminated |
| Reason | Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile product, which could potentially cause a patient infection which is a serious medical condition. |
| Root cause | Packaging change control |
| Action | Angiodynamics, Inc. issued an "Urgent Medical Device Recall" notification (dated 4/28/10). Customers were advised of the affected product and instructed to return all recalled product to the firm. For further information, contact Angiodynamics, Inc. Customer Service at 1-800-772-6446. |
| Quantity | 741 |
| Distribution | Distributed Nationwide and to Italy |
| FDA record | Open on fda.gov |