—#91634

Product

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 product code: KRA — Catheter, Continuous Flush
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K033569, K050205, K082163
Affected lot / code info: Batch Numbers: P909081, P909291, P910092, P910262, P911053, P911163, P911243, P912083, P912293 and P001203.

Why it was recalled

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.

Root cause (FDA determination)

Packaging change control

Action the firm took

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.

Recalling firm

Firm: Angiodynamics, Inc.
Address: 603 Queensbury Avenue, Queensbury, New York 12804

Distribution

Distribution pattern: Distributed Nationwide and to Italy

Timeline

Recall initiated: 2010-04-30
Posted by FDA: 2010-05-28
Terminated: 2012-07-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #91634. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.