Terumo BCT Lakewood, CO 80215, Catalog No 61000 Spectra Optia Apheresis System, Country of Origin: US. Product Usage: Fo
FDA device recall Z-1683-2012 · posted 2012-05-30 · Terminated
Recall details
- Recalling firm
- CaridianBCT, Inc.
- Reason for recall
- Defective product may result in decreased efficacy.
- Action taken
- 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
- Status
- Terminated
- Product code
- LKN
- Quantity affected
- 372 units
- Distribution
- US Nationwide Distribution and the country of Canada.
- Date initiated
- 2012-05-04
- Date posted
- 2012-05-30
- Date terminated
- 2012-11-27
- Location
- Lakewood, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPECTRA OPTIA R APHERESIS SYSTEM (K103090) | Caridianbct, Inc.. | 2010-11-19 |