Recall Z-2422-2015 ยท DTS Sucker, Cardiotomy Return, Cardiopulmonary Bypass
International Biophysics Corp.
IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
| 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 | 100 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
| K963756 | IBC CARDIAC SUCTION WARD International Biophysics Corp., Nov 14, 1997 |