Recall Z-2424-2015— International Biophysics Corp.

Name: FDA recall Z-2424-2015
Creator: U.S. Food and Drug Administration
Published: 2015-08-07

Class II · Terminated

Class II FDA medical device recall by International Biophysics Corp., initiated 2015-08-07, terminated 2016-03-01. FDA's recall record names no specific 510(k) clearance for this event. Product: IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.. Reason: It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria..

Recalling firm: International Biophysics Corp.
Classification: Class II
Status: Terminated
Initiated: 2015-08-07
Terminated: 2016-03-01
Firm location: Austin, TX, United States

Product description

IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.

Reason for recall

It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.

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