International Biophysics Corp.: Medical Device Recall in 2015 - (Recall #: Z-2424-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.
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.

Product Classification:

Class II

Date Initiated: August 7, 2015
Date Posted: August 26, 2015
Recall Number: Z-2424-2015
Event ID: 71911
Reason for Recall:

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

Status: Terminated
Product Quantity: 771 units
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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated