International Biophysics Corp.: Medical Device Recall in 2015 - (Recall #: Z-2423-2015)

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 Aortic Punch Catalog Numbers APM40, APL48A, APM44A, APL40A, APM40A, CVAPL36, CVAPL40, CVAPL44, CVAPL48, CVAPL52, APM28BM, APM36BM, APM40BM, APM44BM, APM48BM, APM40BK, APM48BK, APM36BK, APM44BK, APM28, APM36, APL44, APM40 Product Usage: The IBC Aortic Punch is a single-use, disposable surgical punch used to create an opening in the wall of the aorta to prepare a site for anastomosis.

Product Classification:

Class II

Date Initiated: August 7, 2015

Date Posted: August 26, 2015

Recall Number: Z-2423-2015

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: 10,330 units

Code Information:

042415-3488, 022515-3372, 02215-3374, 022515-3372, 022515-3371, 022515-3373, 022515-3382, 022515-3383, 022515-3384, 022515-3385, 022515-3386, 040615-3452, 040615-3453, 040615-3449, 040615-3450, 040615-3451, 040615-3448, 040615-3447, 050815-3510, 050815-3509, 050815-3511, 050815-3512, 052715-3602, 060315-3603, 031215-3412, 022515-3387, 022515-3388, 033015-3442, 042415-3488

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