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.
FDA Recall Z-1683-2012 · Posted 2012-05-30
Advertisement
Recalling FirmCaridianBCT, Inc.
Recall StatusTerminated
Product CodeLKN
Date Initiated2012-05-04
Date Terminated2012-11-27
Product Quantity372 units
Reason for Recall
Defective product may result in decreased efficacy.
Firm 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 +1.877.339.4228) or +1.303.231.4357, or your local Terum BCT Customer Service Office.
Root Cause
Component design/selection
Distribution Pattern
US Nationwide Distribution and the country of Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement