Recall Z-2030-2014 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 74031-01, 73312-01, 74362, 74928, 74928-01, 72997-03, 74277, 70334-03, 73230, 73728, 71537, 73605-01, 74482-01, 74857-01, 74916, 73928-02, 70123-02, 71853-02, 72997-03, 74766, 71537, 73728, 72269, 7446
| Date | Jul 11, 2014 (initiated Apr 14, 2014) |
| Status | Terminated |
| Reason | During set-up and priming of the bypass circuit, leaks were detected on the centrifugal pumphead. |
| Root cause | Device Design |
| Action | Urgent Medical Device Recall letters, dated April 11, 2014, were sent to customers. The letters identified the affected product, as well as the reason for the correction, the potential hazard, the correction, the affected population, and instructions for customers. Customers are to review the notice and ensure that all users have received a copy. Additionally, customers are to confirm receipt of the communication by returning the attached Customer Response Form as instructed; and, return all effected centrifugal pumps. Terumo CVS will issue a Returned Goods Authorization upon receipt of th |
| Quantity | 256 kits |
| Distribution | Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112229 | SARN CENTRIFUGAL PUMP Terumo Cardiovascular Systems, Dec 9, 2011 |