Food and Drug Administration officials are warning health workers and consumers about infection dangers from several new types of medical swabs and solutions recalled by a Wisconsin firm shuttered because of contamination problems.
Povidone iodine swab sticks, prep solutions, scrubs and gels manufactured by H&P Industries of Hartland, Wis., could pose a “high risk of infection” in surgery patients and others having medical procedures, particularly people with weakened immune systems, according to an FDA safety alert issued Friday. The products were manufactured and distributed without having a process to detect microbial contamination, the alert said.
H&P Industries this week recalled all lots of the povidone iodine products at the FDA’s urging. Firm officials said no direct contamination was found, but the recall was ordered because of the lack of a system in place to detect microbial contamination when the products were released.
The swabsticks were packaged in individual packets of one or three swabs and the prep solution, prep scrub and prep gel were sold in bottles. The products likely were used in hospitals and care centers and sold in stores nationwide.
Click here for a list of recalled products, their brands and distributors.
It’s the latest massive recall for the firm and its sister operation, the Triad Group Inc., whose previously recalled alcohol prep products have been confirmed to be contaminated with Bacillus cereus, a dangerous bacterium blamed for deaths and serious injuries in lawsuits nationwide. The firm also previously recalled povidone iodine prep pads because of microbial contamination with Elizabethkingia meningoseptica.
H&P Industries was shut down in June with a permanent injunction barring the firm from making or distributing products until it met the strict terms of a consent decree and passed FDA muster. Firm officials paid a $4 million penal bond and confirmed they have submitted a “reconditioning plan,” detailing how they hope to repair their manufacturing processes and resume operations.
Neither H&P Industries official nor the FDA would immediately provide a copy of the reconditioning plan to msnbc.com.
The latest warning about infection risks tied to the global supplier of medical products used to clean and sanitize skin before procedures comes amid growing numbers of lawsuits that allege the products caused patient harm.
Patient dies days before Triad deposition
A 68-year-old Alabama woman, Ruby Hutcheson of East Brewton, died on Aug. 20, days before she was scheduled to give a deposition in a lawsuit claiming that contaminated Triad wipes lead to her life-threatening infections. Hutcheson, who suffered from osteoporosis, claimed that she developed severe sores and lesions on her abdomen after injection sites became infected following use of the Triad products. The lesions required multiple surgeries.
The lawsuit, filed in July, claims that the Triad alcohol wipes Hutcheson used were the same as those found to be contaminated with Bacillus cereus, bacteria that can lead to dangerous infections. However, there is no confirmation that Hutcheson’s infections were caused by Bacillus cereus, or that the wipes she used were actually contaminated. Her lawyer, Charles R. Godwin, said results are pending from an autopsy held to determine whether the bacteria contributed to Hutcheson’s death.
The FDA has received more than 200 reports of infections and other problems related to Triad products, documents show. The agency is investigating two deaths that cited Bacillus cereus infections, including a 2-year-old Houston, boy, Harrison Kothari, and a 66-year-old man.