Z-1504-2012

Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000

Name: Z-1504-2012 Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000
Creator: CaridianBCT, Inc.
Published: 2011-10-26
License: https://open.fda.gov/license/

Terumo BCT, Ltd / initiated 2011-10-26 / Terminated / root cause: design

FDA source

CaridianBCT, Inc. began a recall of Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000 on 2011-10-26. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1504-2012
Status: Terminated
Initiated: 2011-10-26
Posted: 2012-05-09
Terminated: 2012-05-11
Recalling firm: Terumo BCT, Ltd
Product: Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.
Product code: LKN Separator, Automated, Blood Cell And Plasma, Therapeutic
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.
Root cause tag: design
FDA 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 in commerce: 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, Finland, France, Germany, Japan, Malaysia, Mexico, Norway, Oman, Pakistan, Philippines, Poland, Portugal, Romania, Russia, Spain, Saudi Arabia, South Africa, Sweden, Switzerland, Taiwan, Thailand, Ukraine, Uruguay, Vatican, Vietnam, and Greece.
Product codes and lots: All serial numbers.

Product code LKN

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)