Recall Z-1901-2008 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Levitronix, Llc
Levitronix CentriMag Primary System, Article Number: 201-30100; extracorporeal blood circulation system.
| Date | Jul 23, 2008 (initiated Mar 17, 2008) |
| Status | Terminated |
| Reason | Stops pumping: Interruption of CentriMag System support may occur when using a Valleylab Force FX-C Electrocautery Unit |
| Root cause | Device Design |
| Action | Levitronix issued an Urgent - Voluntary Device Correction letter on 3/17/08 mailed to the US distributor and requested to contact their accounts. The letter revises the warning in the CentriMag Console Manual. Levitronix is issuing revised manuals. On March 13, 2008 the firm emailed and mailed (FedEx) to the one Canadian Hospital and Health Canada was informed of the Voluntary Advisory Notice via email on Wednesday, March 19, 2008. Rest of the World: Wednesday, March 12, 2008 through Monday, March 17, 2008. The Notice was issued as a Voluntary Advisory Notice after review and follow up wi |
| Quantity | 630 units |
| Distribution | Worldwide Distribution: USA, Canada, Switzerland, UK, Italy, France, Greece, Spain, Slovenia, Czech, Turkey, South Africa, Argentina, Chile, Panama, Singapore, Taiwan, Israel, and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K020271 | LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100 Levitronix, LLC, Mar 25, 2003 |