Recall Z-0140-06 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Terumo Cardiovascular Systems Corp
Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and other devices according to individual customer specifications and then packaged into Custom Cardiovascular Procedure Kits (Convenience Kits) as follows: Convenience Kit Identifier Code/Kit Lot Numbers: 6
| Date | Nov 16, 2005 (initiated Jul 26, 2005) |
| Status | Terminated |
| Reason | Small cracks in the blood chamber may allow air to enter the rotor of the device |
| Root cause | Other |
| Action | Terumo notified consignees by telephone on 7/26/05 and followed by letter dated 7/28/05. Accounts are requested to return product. |
| Quantity | 893 kits |
| Distribution | AZ, CA, KY, IL, LA, MD, WA , WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962981 | CAPIOX SP PUMP HEAD Terumo Medical Corp., Feb 25, 1997 |