December 13, 2005
Baxter says FDA ranks September recall as Class I
CHICAGO (Reuters) - Baxter International Inc. said on
Tuesday U.S. regulators have pegged its September recall of
kidney dialysis equipment a Class I recall, a designation given
to products that could cause serious harm or death.
Baxter on September 28, 2005, issued an urgent product
recall letter to customers over its Meridian hemodialysis
instrument system, instructing them to route blood tubing
through only one of two channel clips to reduce the risk of
Baxter said one death and at least one serious injury have
been associated with kinks in blood tubing.
Baxter said the Class I designation by the U.S. Food and
Drug Administration does not require the return of Meridian
instruments currently in the market.