Home / Recalls / International Biophysics Corp. / Z-2424-2015

Z-2424-2015 Class II Terminated

Recalled by International Biophysics Corp. — Austin, TX

Recall Details

Product Type
Devices
Report Date
August 26, 2015
Initiation Date
August 7, 2015
Termination Date
March 1, 2016
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
771 units

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.

Distribution Pattern

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

Code Information

031715-3418, 050815-3513, 052115-3540, 033015-3435, 052115-3542, 031615-3417, 050815-3514, 052115-3543, 033015-3436, 050815-3515, 060915-3578, 041715-3478, 033015-3437, 050815-3516, 052215-3545, 042015-3482, 052115-3541

Other recalls by International Biophysics Corp.

  • Z-2423-2015 Class II — IBC Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, (August 7, 2015)
  • Z-2422-2015 Class II — IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand i (August 7, 2015)