International Biophysics Corp. recalls IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop i…

Recall date

August 7, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2424-2015

FDA classification

Class II

Brand / firm

International Biophysics Corp.

Sold / distributed

Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.