January 12, 2016 — The FDA is warning healthcare providers not to use surgical convenience packs and trays made by Customed Inc. because they may not be sterile.
According to the Safety Communication, this is the third Class I recall from Customed in the last two years.
The problem is that the sterility of surgical packs may be compromised due to individual packs sticking together inside the shipping case. When the bags are separated, the plastic film can tear and become contaminated. According to the FDA:
“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.”
Additional Class I recalls were issued in June 2014 and expanded in October 2014. In December 2014, the FDA sent the company a warning letter in documenting problems with the sterilization process, packaging design, storage, and manufacturing.
In early 2015, the FDA learned that Customed had resumed distribution. However, follow-up inspections in April confirmed that Customed did not adequately fix problems with packaging and sterility. Several additional Class II recalls were issued in July 2015 due to ongoing concerns about the products.
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