FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015
- Recall number
- Z-0661-03
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter 1550 Single Patient System Hemodialysis Machines; Baxter Healthcare Corporation, Deerfield, IL 60015
- Status
- Terminated
- Initiated
- 2003-02-20
- Posted
- 2003-03-20
- Terminated
- 2006-03-27
- Reason
- Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP)
- Root cause
- Other
- Action
- Baxter sent Safety Alert letters dated 2/20/03 to the end users, informing them of the possibility of either excess or insufficient ultrafiltration when the operator manually controls ultrafiltration via adjustment of transmembrane pressure. The accounts were informed that turning off the UF controller during fault codes FL-04, FL-07 and FL-08 may affect the ability to safely perform manual ultrafiltration, and that treatment should be discontinued if those three fault codes are displayed. Changes to the instructions for use are in process and will be sent to the end users when completed. Additionally, the Baxter 1550 has a side panel that contains a 16-digit display. Currently, during all ultrafiltration system fault modes the display indicates 'Manual UF Control'. To avoid operator confusion, new software is being developed that will provide a display of 'Discontinue TX' when a FL-04, FL-07 or FL-08 fault code occurs. The SPS 550 does not have the side panel display and does not require the software upgrade.
- Quantity
- not on file
- Distribution
- Nationwide and internationally to Algeria, AMerican Samoa, Argentina, Aruba, Australia, Barbados, Belgium, Bolivia, Brazil, Brunei, Burma, Canada, Chile, China, Colombia, Croatia, Cyprus, Dominican Republic, Ecuador, Egypt, El Salvador, Yugoslavia, Germany, Ghana, Guam, Guatemala, Honduras, Hong Kong, Hungary, INdia, Indonesia, Israel, Italy, Jamaica, Jordan, Lebanon, Malaysia, Mexico, Nicaragua, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Romania, Russia, South Korea, Singapore, Slovakia, Slovenia, South Africa, Spain, St. Maarten, Taiwan, Thailand, Tobago, Trinidad, Turkey, United Kingdom, Uruguay, Venezuela and Vietnam.
- Lot, serial or model codes
- catalog #5M5538, 5M5538R, 5M5551, 5M5551R, 5M5575, FM4719, FM4774, FM4779, FM4779R; all serial numbers
- 510(k) numbers
- ["K883111"]
- PMA numbers
- not on file
- Product code
- FKP
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- 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