For more than 40 years, San Diego, CA-based Wallcur has been making products to train healthcare providers, including vets, how to safely and effectively mix and administer injectable drugs and other products so they will know how it is done when they get to the real thing. But the FDA says some of Wallcur's IV training products have made it into the U.S. supply chain and been used on patients with "serious adverse results."
|A Practi-100mL IV Solution Bag with sterile distilled water, which simulates sodium chloride--Courtesy of Wallcur|
The agency warned healthcare providers last week to be sure to read the labels of IV products carefully and not use any Wallcur simulated IV products on human or animal patients. In a MedWatch announcement, the FDA said some healthcare facilities had received and administered some of Wallcur's Practi IV Solution Bags to patients. The agency did not say how the products made it into the supply chain but said it is continuing to investigate and monitor the issue. A spokeswoman told U-T San Diego that because the incident is still under investigation, the agency was not releasing additional info.
Paul Delmore, counsel for the company, said in a phone interview Monday that the company is also still trying to determine how the products ended up being used on patients. "We are really still investigating this," Delmore said. "We found out about this mid last week and with the holiday, we are still trying to get our arms around it." He told U-T San Diego that the Wallcur products are marked "Not for human or animal injection. For clinical simulation only."
The FDA has yet to give Wallcur all of the information the agency has about the incident, Delmore said. "We are not on that end of the information pipeline," he said.
The company does not know how many patients were administered the product, but as of last week the indication was it was fewer than four. The FDA has also told Wallcur how serious the reactions were. Delmore said the company doesn't believe there were any fatal reactions. "If there had been a death, I believe I would have been told," he said.
It has also not been told where the incidents occurred or in what kind of setting, or from whom the end user got the training product. The company usually sells to wholesalers, which then supply training operations, Delmore said. He said Wallcur is contacting all of its customers and asking them to return the products.
While there is the potential for adverse reactions with nearly any product that is being recalled, sometimes even the chance for death, those kinds of problems seldom arise. Last year, Baxter International ($BAX) reported adverse reactions in dialysis patients who had received a peritoneal product that was later found to have mold in it. At the time, the company pointed out that it had not yet been determined if the particulate was the cause of the reactions.