The U.S. Food and Drug Administration (FDA) issued its largest recall of medical products ever in 2014, according to the Regulatory Affairs Professional Society (RAPS). The recall, posted to the FDA’s website in August, was of 233 Class I products manufactured by Puerto Rico-based Customed.
The FDA classifies medical devices and products into three categories: Class I have the least potential to harm a user—Class III products are usually those that sustain life. Class I examples can include bandages, enema kits, and any medical product not necessary to keep a person’s vital organs functioning. Nearly half of all medical products on the market are classified into Class I, according to the FDA.
The devices recalled by Customed were recalled because of packaging flaws. The products were primarily sterile convenience packs; the recall was initiated because of “adhesion in the sterile packaging,” according to RAPS. If the product was used on a patient, it had the potential to not be sterile and lead to infection, though as of September, no cases had been discovered of a person suffering an infection or side effects because of Customed products. The FDA generally does not wait until a case of injury has been discovered to recall medical products; once the manufacturer is aware of the problem, it is responsible to initiate a recall immediately.
According to RAPS, the FDA recalls up to 75 devices every day. The rate at which devices are recalled has steadily increased in recent years—in part due to a relatively new FDA regulatory system that allows certain devices to be available on the consumer market without extensive testing or review. Yet the number of “major device recall events” has decreased at the same time. Even still, the Customed recall is the largest recall of devices to date, according to RAPS.
The devices recalled are used primarily for surgical interventions in dental, ENT, cardiovascular, neurology, obstetrical, ophthalmic and anesthesiology procedures, according to a Customed press release.
If you have undergone any of these procedures in the past year and suspect that you may have gotten an infection from unsterile bandage packs, you could be eligible for compensation. Do not go through it alone. Contact an Arlington Heights defective medical product attorney today.
