Recall Z-1683-2012 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
CaridianBCT, Inc.
Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US. Product Usage: For use in humans. Within the US marketplace, this device is approved for use in Therapeutic Plasma Exchange. Internationally, this device is approved for use in Mono Nucleo Cell engraftment.
| Date | May 30, 2012 (initiated May 4, 2012) |
| Status | Terminated |
| Reason | Defective product may result in decreased efficacy. |
| Root cause | Component design/selection |
| Action | Terumo BCT sent a Voluntary Medcal Device Safety Alert letter dated May 18, 2012 to each of their consignees via certified letter. The letter identified the affected product, problem, actions to be taken and instructions for healthcare providers until a corrective action is identified and implemented. Customers were instructed to share this safety alert with all those who need to be aware and complete the attached Acknowledgement Form and fax to +1.303.876.9277 or email to Terumo BCT. For questions contact your Terumo BCT Representative, the Terumo BCT Support Center at (U.S. Toll Free +1. |
| Quantity | 372 units |
| Distribution | US Nationwide Distribution and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103090 | SPECTRA OPTIA R APHERESIS SYSTEM Caridianbct, Inc.., Nov 19, 2010 |