New deaths prompt kidney filter recall

The patients died during or straight after dialysis

An American healthcare product company has announced a global recall of its kidney dialysis equipment following dozens of patient deaths in Europe and the US.

The recall by Baxter International came as two kidney patients died suddenly in the US state of Texas during a dialysis session using blood-cleaning filters produced by the company.

There is no information linking these deaths to the dialyzer made by Baxter

Tanya Tyska, Baxter spokeswoman

Twenty-one patients in Croatia died earlier this month either during or immediately after their dialysis sessions, while in Spain at least 12 similar deaths have been reported.

The US Food and Drug Administration, which oversees the manufacture and distribution of medical products, is investigating the deaths in Texas.

Meanwhile, Baxter has sent a team of medical investigators to Texas, Spain and Croatia, and says it has invited an independent body to audit its manufacturing facilities in Sweden.

The equipment is not used in the UK.

"Precaution"

Baxter nonetheless maintains that there is no evidence to suggest that its equipment is responsible for the spate of deaths, and has described accusations as "premature".

"There is no information linking these deaths to the dialyzer made by Baxter," spokeswoman Tanya Tyska told the AP news agency.

The Croatian prime minister says initial findings point to Baxter

"We've instituted the recall as a precaution until an investigation into all aspects of their treatment is completed," she said, adding that the filters are only one element of the blood-cleaning process.

The Spanish Government has been carrying out its own tests into the deaths, while Croatian authorities have declared that the initial findings point clearly to Baxter's filters.

Health Minister Ana Stavljenic-Rukavina says the death rate among the country's kidney patients has returned to normal levels since the Baxter dialyzers were replaced with other brands.

Her ministry has come under fire for the delay in warning hospitals of possible dangers.

There was a four day lapse between the first deaths in Croatia and all of the country's hospitals being alerted to the threat.

Zagreb has now announced plans to pay compensation to the families of those who died.