Recall Z-0078-2008 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
Gambro BCT, Inc.
Spectra Optia apheresis system, a blood component separator. Part No. 61000, Gambro BCT Lakewood, CO USA 80215.
| Date | Oct 31, 2007 (initiated Sep 18, 2007) |
| Status | Terminated |
| Reason | Under specific conditions, apheresis machine could return up to 60mL of air to the patient. |
| Root cause | Software design |
| Action | All consignees were notified by telephone beginning 09/17/2007. They were given instructions on how to safely use the machine. Letters were also sent on 09/22/2007 restating the information. |
| Quantity | 15 units |
| Distribution | US, Canada, Australia, Europe. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K071079 | SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 Gambro Bct, Inc., Aug 2, 2007 |