FDA Medical Device Recalls (openFDA)
CaridianBCT, Inc.: Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.
- Recall number
- Z-1504-2012
- Recalling firm
- CaridianBCT, Inc.
- Product
- Caridian BCT COBE Spectra System Blood Warmer, Catalog number 950000000.
- Status
- Terminated
- Initiated
- 2011-10-26
- Posted
- 2012-05-09
- Terminated
- 2012-05-11
- 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, 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.
- Lot, serial or model codes
- All serial numbers.
- 510(k) numbers
- ["K071079","K103090"]
- PMA numbers
- not on file
- Product code
- LKN
- Firm FEI
- 1000117351
- Firm city
- Lakewood
- Firm state
- CO
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28