Class 2 Device Recall COBE Spectra

• Date Initiated by Firm: October 26, 2011
• Date Posted: May 09, 2012
• Recall Status: Terminated on May 11, 2012
• Recall Number: Z-1504-2012
• Recall Event ID: 53828
• 510(K)Number: K071079 K103090
• Product Classification: blood warmer - Product Code LKN
• Product: Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.
• Code Information: All serial numbers.
• Recalling Firm/ Manufacturer: CaridianBCT, Inc.; 10811 W Collins Ave; Lakewood CO 80215-4440
• For Additional Information Contact: 303-231-4718
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LKN and Original Applicant = CARIDIANBCT, INC.; 510(K)s with Product Code = LKN and Original Applicant = GAMBRO BCT, INC.