Recall Z-1112-2012 ยท KRA Catheter, Continuous Flush
Angiodynamics Worldwide Headquarters
AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60035 --- Manufactured in USA --- [Mfg symbol] AngioDyanamics, 603 Queensbury Avenue, Queensbury, NY USA 12804. Intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agents to the kidneys via the renal arteries.
| Date | Feb 28, 2012 (initiated Feb 6, 2012) |
| Status | Terminated |
| Reason | The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks. |
| Root cause | Nonconforming Material/Component |
| Action | Field Safety Notices (FSNs), entitled Urgent - Medical Device Recall, were sent to consignees on 02/06/2012 via USPS certified mail, return receipt requested. The letters identified the affected devices, the issue, hazard involved, and actions to be taken by the customer and AngioDynamics. The FSN directs consignees to identify and segregate the recalled lots, returning any affected product to AngioDynamics, Inc., Queensbury, NY 12804. The Recall Reply Form should be completed and faxed to 518-798-1360. --- If customers have distributed the affected product/lot, they are instructed to infor |
| Quantity | 11 units |
| Distribution | Nationwide Distribution -- Florida, Iowa, Maryland, New York, and Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082163 | FLOWMEDICA BENEPHIT INFUSION SYSTEMS Flowmedica, Inc., Oct 29, 2008 |