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Terminated

ANGIODYNAMICS BENEPHIT(TM) XT Infusion System, 35 cm, Targeted Renal Therapy Infusion system, Model/REF Number 70035, STERILE, EO, Intended for Single Use Only. AngioDynamics, Incorporated 603 Queensbury, NY 12804.

FDA Recall Z-1733-2010 · Posted 2010-05-28

Recalling FirmAngiodynamics, Inc.
Recall StatusTerminated
Product CodeKRA
Date Initiated2010-04-30
Date Terminated2012-07-25
Product Quantity741

Reason for Recall

Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile product, which could potentially cause a patient infection which is a serious medical condition.

Firm Action

Angiodynamics, Inc. issued an "Urgent Medical Device Recall" notification (dated 4/28/10). Customers were advised of the affected product and instructed to return all recalled product to the firm. For further information, contact Angiodynamics, Inc. Customer Service at 1-800-772-6446.

Root Cause

Packaging change control

Distribution Pattern

Distributed Nationwide and to Italy

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K082163FLOWMEDICA BENEPHIT INFUSION SYSTEMSFlowmedica, Inc. · 2008-10-29K050205BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATHFlowmedica, Inc. · 2005-03-04K033569FLOWMEDICA BIFURCATED INFUSION SYSTEM, INFUSION CATHETER AND INTRODUCER SHEATHFlowmedica, Inc. · 2004-01-13

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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