Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.
FDA device recall Z-1504-2012 · posted 2012-05-09 · Terminated
Recall details
- Recalling firm
- CaridianBCT, Inc.
- Reason for recall
- Potential for air entry into the fluid pathway of the COBE Spectra due to a leak at the return luer connection to an elevated bloodwarmer when directions for use are not followed.
- Action taken
- Caridian BCT sent a letter to customers dated June 2011. It was a Field labeling addendum to the COBE Spectra Apheresis System Operator's Manual stating: "When connecting a blood warmer tubing set to the return line, ensure that the tubing connection is tight. Put the luer connection no higher than 20 in (50 cm) above the return access to prevent the possibility of air entering the tubing." This correction was distributed to all consignees and is included with the current version of the owner's manual.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LKN
- Quantity affected
- 2459 machines
- Distribution
- Worldwide distribution including USA, Canada, Algeria, Argentina, Australia, Austria, Bahamas, Belgium, Brazil, Chile, China, Colombia, Czech Republic, Denmark, Netherlands, UK, Hong Kong, Hungary, In
- Date initiated
- 2011-10-26
- Date posted
- 2012-05-09
- Date terminated
- 2012-05-11
- Location
- Lakewood, CO
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SPECTRA OPTIA R APHERESIS SYSTEM (K103090) | Caridianbct, Inc.. | 2010-11-19 |
| SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200 (K071079) | Gambro Bct, Inc. | 2007-08-02 |