Z-1113-2012

AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60030...

Name: Z-1113-2012 AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60030...
Creator: Angiodynamics Worldwide Headquarters
Published: 2012-02-06
License: https://open.fda.gov/license/

Angiodynamics Worldwide Headquarters / initiated 2012-02-06 / Terminated / root cause: manufacturing process

FDA source

Angiodynamics Worldwide Headquarters began a recall of AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60030 --- Manufactured in USA --- [Mfg symbol]... on 2012-02-06. The reason FDA records is "The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks". 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-1113-2012
Status: Terminated
Initiated: 2012-02-06
Posted: 2012-02-28
Terminated: 2016-02-10
Recalling firm: Angiodynamics Worldwide Headquarters
Product: AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60030 --- 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.
Product code: KRA Catheter, Continuous Flush
Reason for recall: The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks.
Root cause tag: manufacturing process
FDA 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 inform their customers of this recall action immediately, and then return the recalled units. --- If customers have any additional questions or concerns or need more detailed instruction on how to comply with this notice, please contact the local sales representative or call Julie Blair, Customer Service Manager, at ANGIODYNAMICS Customer Service at 1-800-772-6446. Customers may also e-mail questions to [email protected]
Quantity in commerce: 4 units
Distribution: Nationwide Distribution -- Florida, Iowa, Maryland, New York, and Texas.
Product codes and lots: Lot 550790

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)