Surgical kit maker Custom Medical Specialties used recalled iodine prep solution in its products prompting the FDA to issue a Class I recall of 14 products. The recalled iodine has been linked to serious adverse reactions, including iodine prep solution death.
Recalled Iodine Prep Solution Left In Products
The problem stared last year when the FDA issued a recall of Povidone Iodine Prep Solutions (H&P Industries) for failing to conduct microbial testing prior to selling it. Iodine prep solution deaths were reported as the fluid carried a huge risk of contamination. Notice of the FDA’s recall of the iodine prep solution was sent on September 27, 2011. However, Custom Medical Specialities did not stop using the recalled iodine in 14 of their products.
Patients undergoing medical and surgical procedures, including those who are immunocompromised, have a high risk of infection from antiseptic surgical preparations that have been prepared, packaged, or held under insanitary conditions.
FDA’s September 27, 2011 Recall Notice of Povidone Iodine Prep Solution
Povidone Iodine Swabsticks, Povidone Iodine Prep Solutions, Povidone Iodine Scrub Solutions, and Povidone Iodine Prep Gel are labeled as an antiseptic for preparation of the skin prior to surgery, and are used to prevent infection in minor cuts, scrapes and burns. The Povidone Iodine Scrub solutions are labeled also for use as a surgical hand scrub for health care professionals.
The Povidone Iodine products were distributed nationwide to healthcare customers. The swabsticks are packaged in individual packets of 1 or 3 swabs and the Prep Solution, Scrub Solution and Prep Gel are sold in bottles.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Recalled Custom Medical Specialities products include: the HSG Tray, Hysteroscopic Sterilization Pack, Vein Tray, Amnio Tray, Fox Chase Specials Pack, Abington Radiology Drainage Pack, CT Biopsy Tray, Myelogram Tray, and Hysteroscopy Sterile Procedure Kit.