Benephit XT Infusion System, Targeted Renal Therapy Infusion System, Catalog/REF 70035, STERILE -- AngioDynamics Inc. 60

FDA device recall Z-0509-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Angiodynamics Worldwide Headquarters

Reason for recall

The Benephit XT Infusion System may contain hairline cracks in the sheath hub.

Action taken

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

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

KRA

Quantity affected

55 units domestically

Distribution

Nationwide Distribution including the states of New York, Pennsylvania, Virginia, Kentucky, Iowa, Illinois, Missouri, Louisiana, Texas, and Utah.

Date initiated

2011-12-05

Date posted

2012-01-11

Date terminated

2016-01-29

Location

Latham, NY

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