FDA-Device2015-08-26Class II
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.
International Biophysics Corp.
Hazard
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Sold states
Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa
Affected count
771 units
Manufactured in
Bldg 2, Ste 275, 2101 E Saint Elmo Rd, Austin, TX, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2424-2015Don't want to check this manually?
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