Recall Z-1504-2012 ยท LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
CaridianBCT, Inc.
Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.
| Date | May 9, 2012 (initiated Oct 26, 2011) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 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, India, Italy, Iran, Ireland, Israel, Jordan, Korea, Kuwait, Lebanon, Libya, Luxembourg, Egypt, Finlan |
| FDA record | Open on fda.gov |