Device product
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.
Z-2423-2015
Product summary
- Event
- Event 71911
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,330 units
- Official record key
device-enforcement:Z-2423-2015
Official wording
Reason: It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
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
Derived failure modes
-
Unknown
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.