Z-0509-2012

Benephit XT Infusion System, Targeted Renal Therapy Infusion System, Catalog/REF 70035, STERILE...

Name: Z-0509-2012 Benephit XT Infusion System, Targeted Renal Therapy Infusion System, Catalog/REF 70035, STERILE...
Creator: Angiodynamics Worldwide Headquarters
Published: 2011-12-05
License: https://open.fda.gov/license/

Angiodynamics Worldwide Headquarters / initiated 2011-12-05 / Terminated / root cause: manufacturing process

FDA source

Angiodynamics Worldwide Headquarters began a recall of Benephit XT Infusion System, Targeted Renal Therapy Infusion System, Catalog/REF 70035, STERILE -- AngioDynamics Inc. 603 Queensbury, NY 12804 USA ---... on 2011-12-05. The reason FDA records is "The Benephit XT Infusion System may contain hairline cracks in the sheath hub". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0509-2012
Status: Terminated
Initiated: 2011-12-05
Posted: 2012-01-11
Terminated: 2016-01-29
Recalling firm: Angiodynamics Worldwide Headquarters
Product: 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 agents to the kidneys via the renal arteries. The Benephit Infusion Systems are indicated for use in patients undergoing medical, interventional, or surgical procedures, where the procedure carries an elevated risk of iatrogenic kidney injury for the patient. The Benephit Infusion Systems are also indicated to facilitate TRT in patients who have demonstrated symptoms of acute kidney injury, and whom arterial catheterization for TRT is feasible.
Product code: KRA Catheter, Continuous Flush
Reason for recall: The Benephit XT Infusion System may contain hairline cracks in the sheath hub.
Root cause tag: manufacturing process
FDA 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 by each consignee. ACTIONS TO BE TAKEN BY CUSTOMER / USER: (1.) Identify and segregate the recalled lots that are in your possession. (2.) Complete the enclosed Benephit XT Infusion System Recall Reply Form and fax it to the attention of the Benephit XT Infusion System Recall Coordinator at 518-798-1360. The form lists the catalog number, lot numbers, and quantity our records indicate your facility has received. It is important that even if you do not have any product remaining in your possession that you fill out the attached form noting zero quantity to be returned and fax the form to ANGIODYNAMICS. (3.) Ship the recalled product to ANGIODYNAMICS. Replacement product will be shipped upon receipt and confirmation of the returned product. Reference Return Authorization Number on the outside of the shipping box and include a copy of the Benephit Infusion System Recall Reply Form with your shipment. (4.) If you have distributed the affected product/lot, please inform your customers of this recall action immediately, and have them return the recalled units to you. --- Certified Mail will verify delivery to each domestic consignee. Non-respondents will be contacted by telephone or via e-mail. --- Corrective Action: Returned product will be quarantined and final disposition has not been determined at this time. A corrective action has been initiated by AngioDynam
Quantity in commerce: 55 units domestically
Distribution: Nationwide Distribution including the states of New York, Pennsylvania, Virginia, Kentucky, Iowa, Illinois, Missouri, Louisiana, Texas, and Utah.
Product codes and lots: Lot C23415

Product code KRA

K082163Class IIFlowmedica Benephit Infusion SystemsFlowmedica, Inc. / cleared 2008-10-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)