Organ Transplant Storage Fluid Recalled Due to Potential Contamination

Due to a potential risk of bacterial contamination, a world-wide recall has been issued for Viaspan, a fluid used to store organs slated for transplant. 

Bristol Myers-Squibb and British health officials announced the Viaspan recall on Thursday, after the bacteria Bacillus cereus was found in the production line by a third party in Austria on March 19.

According to the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA), the organ transplant fluid recall affects all batches of Viaspan manufactured since July 8 and 9, 2011. However, there have been no reports of infections or adverse events associated with the organ transplant fluid recall.

“There is no evidence from transplant centres that patients who have had transplants using this solution are experiencing any related healthcare problems,” Professor Kent Woods, Chief Executive of the MHRA, said in the press release. “We have acted quickly to protect patients and we have alerted transplant centres and surgeons immediately about this contamination and precautionary recall by the manufacturer.”

Bristol Myers-Squibb officials indicate that they have notified health authorities in every country where Viaspan was distributed. The company said that the cause of the contamination is still under investigation and it will release updates when more information is available.

The recall has been described by Bristol Myers-Squibb officials as a precautionary action, maintaining that there is no evidence that there was actual contamination of the fluid itself, just that contamination was found on the production line.

Bacillus cereus is responsible for about two percent of all foodborne illness, according to the U.S. Centers for Disease Control and Prevention (CDC). Illness comes within 24 hours after exposure and can result in a diarrheal illness. Serious illness and permanent injury are very rare.

The same bacteria was linked to the recall of millions of Triad alcohol wipes and prep pads last year. Contaminated Triad wipes made by H&P Industries have been linked to at least 8 deaths, 11 cases of infection and more than 250 consumer complaints.