On August 29, 2014, the FDA issued 233 Class I medical device recalls for products manufactured by Customed. According to its website, Puerto Rico-based Customed is a medical supplies leader and distributes a wide range of products to many hospitals and thousands of doctors’ offices, hospices, laboratories, radiology centers, pharmacies and other healthcare facilities.
According to the FDA’s website, Customed voluntarily recalled the 233 devices due to packaging flaws. The devices recalled include various medical and surgical packs (e.g., laparotomy pack, femoral pack, labor & delivery pack, open heart tray pack, etc.), all having sterile packaging. The device supplier stated in a recent press release that the sterile convenience surgical packs were found to have potential defects in packaging adhesion that could result in a loss of product sterility and subsequent patient infection. The Regulatory Affairs Professionals Society (RAPS) estimates the number of affected units to be several hundred thousand. As of August 21, 2014, no serious injuries or deaths were reported.
According to the FDA’s website, medical device recalls remove a product from the market and may be conducted on a company’s own initiative, by FDA request, or by FDA order under statutory authority (21 CFR § 810.1 et seq.). To reflect varying severity of risk presented by different devices being recalled, FDA recalls are categorized as Class I, Class II, or Class III. Those classes are defined as follows:
Class I recall: a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Class II recall: a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III recall: a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
RAPS reports that, aside from a few statistical outliers, the overwhelming majority of all FDA medical device recalls are either Class II or Class III recalls (reflecting “lesser (and non-deadly)” safety risks). In fact, since 2004, Class I, Class II, and Class III recalls comprised 6%, 86%, and 7% of total recalls, respectively. While the FDA typically recalls 13-75 devices daily, RAPS reports that there have historically been relatively few major device recalls despite an overall upswing in the number of recall events since 2012.
According to RAPS, the Customed device recall represents the single largest FDA recall to date, regardless of class, and is more than 9 times larger than the second largest Class I recall (which occurred on March 5, 2014).