January 12, 2016 — The FDA is warning hospitals not to use Customed convenience packs and trays for surgical procedures because they may not be sterile and could cause infection or death.
The sterility of medical devices used in surgery is extremely important to prevent infections. Customed has now issued three Class I recalls numerous additional Class II recalls for products made since 2009 in Puerto Rico.
The problem is that the plastic packaging can get stuck together during the sterilization process. When separated, the packaging could tear and allow microorganisms inside. The FDA warns:
“There is significant risk of compromised sterility and use of a contaminated product, whether the package is damaged or not. The products have been exposed to uncontrolled and inadequate storage conditions and there are serious deficiencies in the manufacturing process.”
Customed initiated a recall in June 2014 due to potential contamination. In October, Customed expanded the recall and stopped distribution. The FDA inspected Customed and issued a warning letter in December 2014 about problems with sterility and package design.
Surgical convenience packs and trays may contain items like exam gloves, absorbent towels, gauze sponges, surgical table covers, gowns, and suture kits. They are widely used in general surgery, including dental, obstetrical, and gynecological procedures.
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