Z-2423-2015 Class II Terminated
FDA device recall Z-2423-2015 was initiated by International Biophysics Corp. on August 7, 2015 and is designated Class II. Reason for recall: It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. The recall status is terminated (terminated March 1, 2016). Affected quantity: 10,330 units.
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
- 10,330 units
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.
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
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