Recall Z-0509-2012 ยท KRA Catheter, Continuous Flush
Angiodynamics Worldwide Headquarters
Benephit XT Infusion System, Targeted Renal Therapy Infusion System, Catalog/REF 70035, STERILE -- AngioDynamics Inc. 603 Queensbury, NY 12804 USA --- COMMON/USUAL NAME - Continuous flush catheter; CLASSIFICATION NAME: Continuous flush catheter; Device Listing # D069932 Benephit Infusion Systems are intended to facilitate targeted renal therapy, or TRT, the delivery of physician-specific agent
| Date | Jan 11, 2012 (initiated Dec 5, 2011) |
| Status | Terminated |
| Reason | The Benephit XT Infusion System may contain hairline cracks in the sheath hub. |
| Root cause | Nonconforming Material/Component |
| Action | Angiodynamics Worldwide Headquarters sent a Urgent Medical Device Recall Letter and Response Forms dated December 2, 2011, to all affected customers via Certified Mail on December 5, 2011. The recall is being extended to the medical user level. Customers will be instructed not to use the product and to return it to AngioDynamics, Inc. in Queensbury, NY. A Return Authorization number (RA #) will be assigned to each customer in the recall notification letter and a UPS account will be provided for return freight. A reply form was provided with the recall notification letter to be completed |
| Quantity | 55 units domestically |
| Distribution | Nationwide Distribution including the states of New York, Pennsylvania, Virginia, Kentucky, Iowa, Illinois, Missouri, Louisiana, Texas, and Utah. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K082163 | FLOWMEDICA BENEPHIT INFUSION SYSTEMS Flowmedica, Inc., Oct 29, 2008 |