Recall Z-2423-2015 ยท DWS Instruments, Surgical, Cardiovascular
International Biophysics Corp.
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.
| Date | Aug 19, 2015 (initiated Aug 7, 2015) |
| Status | Terminated |
| Reason | It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. |
| Root cause | Packaging process control |
| Action | The recalling firm began notifying their affacted customers on 7/2/2015 |
| Quantity | 10,330 units |
| Distribution | Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.