FDA Issues Recall for Contaminated Ultrasound Gel
The U.S. Food and Drug Administration has issued a recall of a specific brand of ultrasound gel after it was determined that the gel was contaminated with potentially harmful bacteria.
At the direction of the FDA, U.S. Marshals seized several lots of Other-Sonic Generic Ultrasound Transmission Gel manufactured by Pharmaceutical Innovations Inc. in Newark, N.J. The recall involves all lots of the gel manufactured between June 2011 and December 2011. The seizure was ordered after analysis of gel samples collected in February 2012 indicated the presence of two strains of bacteria, Pseudomonas aeruginosa and Klebsiella oxytoca. The FDA has also recommended health care professionals to avoid using 250 milliliter bottles and 5-liter dispensing containers of the gel featuring the lot numbers 060111, 090111 and 120111.
Reportedly, 16 patients from the same hospital have been sickened by the contaminated gel after being exposed to the bacterial strains. All of the cases involved patients who underwent transesophageal ultrasound procedures while undergoing heart valve replacement surgery. Radiologists, urologists, gastroenterologists, OB-GYNs, internists, nurses and ultrasound technicians use the gel for diagnostic ultrasound testing. The gel may also be used by chiropractors and physical therapists for ultrasound treatment of pain, inflammation and injuries.
While there have been no reports of pregnant women being adversely affected by the contaminated gel, the possibility remains that there may be continued cases of infection. Specifically, the FDA has warned that patients who have been exposed to the ultrasound gel may be at risk for pneumonia, wound infections or blood infections if exposed to the bacteria. Health care providers have been asked to review patient data in order to identify any individuals who may have been exposed to the bacteria. Patients who believe they may have developed an infection caused by the contaminated ultrasound gel are urged to file a report with MedWatch, the FDA’s adverse event reporting program.
In cases where someone is injured or becomes ill because of a defective product, the victim may be entitled to compensation for their medical bills, lost wages and pain and suffering. An experienced California product recall attorney can evaluate the circumstances of your case and help you to determine what, if any, damages you may be entitled to. If you or a loved one believes a defective product was responsible for your injury illness, you need to get in touch a qualified product liability lawyer to determine whether your legal rights are.
Nadrich & Cohen, LLP specializes in representing victims who are injured by defective and dangerous products. For more information on filing a product liability lawsuit, call 1-800-718-4658 to begin your free initial case evaluation. There is never a fee unless damages are recovered on your behalf.