Recall Z-0870-2013— Medrad Inc

Name: FDA recall Z-0870-2013
Creator: U.S. Food and Drug Administration
Published: 2012-11-05

Class II · Terminated

Class II FDA medical device recall by Medrad Inc, initiated 2012-11-05, terminated 2015-03-10. It names one FDA 510(k) clearance: K050456. Product: MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.. Reason: The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory..

Recalling firm: Medrad Inc
Classification: Class II
Status: Terminated
Initiated: 2012-11-05
Terminated: 2015-03-10
Firm location: Warrendale, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K050456 — MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEMMedrad, Inc.·cleared 2005-06-17

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MEDRAD Hand Controller Sheath, Catalog number AVA 500 HCS/3010903, for cardiac catheterization procedures. The Sterile Sheath is specifically intended for use in the x-ray angiography environment to cover the Medrad Avanta Sterile Hand Controller to prevent cross contamination between patients.

Reason for recall

The seal between the white polyethylene and the clear plastic may be missing on the Hand Controller Sheath package, resulting in a potential breach of the sterility of this accessory.

Data sourced from openFDA. This site is unofficial and independent of the FDA.