AngioDynamics BENEPHIT CV Infusion System Targeted Renal Therapy Infusion System --- Catalog No. [REF] 60035 --- Manufac

FDA device recall Z-1112-2012 · posted 2012-02-28 · Terminated

Recall details

Recalling firm

Angiodynamics Worldwide Headquarters

Reason for recall

The Benephit CV Infusion System contains a Sheath Y Connector that has the potential to develop cracks.

Action taken

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 customerservice@angiodynamics.com

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KRA

Quantity affected

11 units

Distribution

Nationwide Distribution -- Florida, Iowa, Maryland, New York, and Texas.

Date initiated

2012-02-06

Date posted

2012-02-28

Date terminated

2016-02-10

Location

Latham, NY

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