Class 1 Recall: Baxter Healthcare Corp. Meridian® Hemodialyis (HD) Instrument

Date Recall
Initiated:

September 28, 2005

Product:

Baxter Meridian® Hemodialyis (HD) Instrument (Product Codes 5M5576 and 5M5576R)

Use:

The Baxter Meridian® is a single patient hemodialysis instrument that prepares dialysis solution, circulates blood through an external tubing system and hemodialyzer, and monitors the system for operating conditions.

Recalling Firm:

Baxter Healthcare Corporation
1620 Waukegan Rd. , Bldg. R
McGaw Park , IL 60085-6730

Reason for Recall:

There have been reports of hemolysis (broken blood cells) related to kinks in the blood tubing sets used with the Meridian®. To date, there have been reports of at least one death and one serious injury, associated with kinking of blood tubing sets routed through both channels of the two channel clips mounted on the front of the Meridian®. The original labeling for the device is inadequate because it instructs users to route the blood tubing sets through both channels of the two-channel clips.

Public Contact:

Center for One Baxter
Baxter Healthcare Corporation
1 Baxter Parkway
Deerfield , IL 60015
800-422-9837

FDA District:

Chicago

FDA Comments:

• Baxter notified its customers of the problem in an “Urgent Product Recall” letter dated September 28, 2005 . FDA classified this action as a Class I Recall. Class I recalls are the most serious types of recalls and involve situations in which there is a reasonable probability that use of the affected product may cause serious injury or death if the problem is not corrected.
• This classification does not require the return of Meridian® instruments currently in the market.
• In the September 28, 2005 , notification, regarding the Meridian® Hemodialyis (HD) Instrument, Baxter directs customers to route blood tubing through only one channel of the two channel clips mounted on the front of the Meridian to reduce the risk of blood tubing kinks. Baxter's letter to customers is available on its Web site at http://www.baxter.com.
• Baxter provided labels with the September 28, 2005 , notification, to be affixed to Meridian® instruments. The labels display the proper routing of the blood tubing sets through the two channel clips. Further, Baxter asks that all care providers be trained and that they follow the proper set up and use only one of the two channels of the two channel clips during treatment. Continuous verification through visual inspection of the tubing will reduce the chances of kinking. In addition, Baxter will be providing modified tubing clips to eliminate related safety issues as soon as possible.

Consumers with questions about the recall may contact the company at (800) 422-9837. Those who have technical questions may contact the company at (800) 553-6898. Baxter's letters to customers and press releases are available on its web site at www.Baxter.com.