Terminated

Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.

FDA Recall Z-1504-2012 · Posted 2012-05-09

Recalling FirmCaridianBCT, Inc.

Recall StatusTerminated

Product CodeLKN

Date Initiated2011-10-26

Date Terminated2012-05-11

Product Quantity2459 machines

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.

Firm 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.

Root Cause

Device Design

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K103090SPECTRA OPTIA R APHERESIS SYSTEMCaridianbct, Inc.. · 2010-11-19 K071079SPECTRA OPTIA APHERESIS SYSTEM, SPECTRA OPTIA EXCHANGE SET, MODEL 61000, 10200Gambro Bct, Inc. · 2007-08-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.