Recall Z-1417-2014— Aspen Surgical Products, Inc.

Name: FDA recall Z-1417-2014
Creator: U.S. Food and Drug Administration
Published: 2014-03-20

Class II · Terminated

Class II FDA medical device recall by Aspen Surgical Products, Inc., initiated 2014-03-20, terminated 2014-11-25. FDA's recall record names no specific 510(k) clearance for this event. Product: 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage. Reason: The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices..

Recalling firm: Aspen Surgical Products, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-03-20
Terminated: 2014-11-25
Firm location: Caledonia, MI, United States

Product description

7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (10/case) Intended for closed wound suction drainage

Reason for recall

The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.

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