FDA Medical Device Recalls (openFDA)
Baxter Healthcare Renal Div: Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
- Recall number
- Z-0275-06
- Recalling firm
- Baxter Healthcare Renal Div
- Product
- Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
- Status
- Terminated
- Initiated
- 2005-09-28
- Posted
- 2005-12-14
- Terminated
- 2006-11-27
- Reason
- Inadequate instructions for routing single tubing lines through the double-tubing clips on the front of the instrument to eliminate the risk of kinks in the tubing, which have been associated with a death and a serious injury.
- Root cause
- Other
- Action
- Urgent Device Recall letters dated 9/28/05 were sent to all Meridian accounts on the same date, to the attention of the Hemodialysis Administrator, with copies sent to the Chief Technician and Hemodialysis Charge Nurse. The letters informed the accounts of teh death and serious injury related to kinks in blood tubing sets used on the Meridian machine, and that there is an increased risk of kinks to occur at the double-tubing clips mounted on the front of the Meridian. The risk increases when a single tubing line is routed through both retainers on either clip. The letter included diagrams showing the correct and incorrect use of the clips, provided labels, with placement instructions, to be placed on the Meridian machine indicating the correct and incorrect placement of tubing, and informed the users that replacement clips with single channels will be installed when they become available. Follow-up letters were sent to the accounts on 12/22/05, providing training material to ensure that the accounts are aware of proper blood tubing set-up and understand the conditions which may result in hemolysis, and on 12/23/05, informing them that the replacement clips were available for installation, giving the accounts the option of having Baxter install them or sending the clips to the account for self-installation.
- Quantity
- 2,838 units
- Distribution
- Nationwide and internationally to Mexico and Asia.
- Lot, serial or model codes
- all serial numbers, beginning with 20000
- 510(k) numbers
- ["K992894"]
- PMA numbers
- not on file
- Product code
- KDI
- Firm FEI
- 3000210122
- Firm city
- Park
- 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