FDA Issues “Do Not Use” Warning For Surgical Convenience Packs and Trays by Customed, Inc

Government health officials are warning medical providers to immediately stop using certain surgical convenience packs and trays distributed in Puerto Rico, after discovering the packs may not have been adequately tested to ensure sterilization. 

The Customed’s Surgical Convenience Packs and Trays warning was issued by the FDA on January 5, after determining the surgical procedure packs have not gone through proper sterilization testing procedures mandated by the FDA.

The FDA is warning doctors and physicians to stop using the packs immediately due to the potential for the surgical kits to cause infection and surgical complications.

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The Customed’s Surgical Convenience Packs or Trays are prepackaged kits containing surgical instruments and equipment used by healthcare physicians. The surgical convenience packs include items such as exam gloves, absorbent towels, suture bags, surgical table covers and drapes. The prepackaged surgical trays include items such as sodium chloride irrigation bottles, catheters, needles and syringes.

The FDA is asking healthcare physicians to stop using the kits immediately after discovering the kits have not been properly tested for sterility, proper endotoxin and ethylene oxide levels, package integrity to withstand stresses during transport, nor have they been kept to standards for expiration.

The surgical packages were manufactured by Customed Inc. of Fajardo, Puerto Rico and were used only in healthcare facilities in Puerto Rico according to the FDA. The FDA’s warning letter is a continuing follow-up to monitor Customed Inc.’s testing requirements after the FDA issued a string of recalls for prepackaged products made by the manufacturer between October 2014 and September 2015 for sterilization hazards.

Many of the FDA’s recalls for Customed Inc. prepackaged surgical trays and kits were the result of packaging defects that during transport could potentially rip or tear. Along with sterilization and other requirements the FDA mandates, packaging is one of the most important because if the packaging is ripped and exposes the kits to outside elements, microorganism could enter and contaminate the surgical tools.

Healthcare physicians in Puerto Rico are being asked to stop using the Customed Inc. prepackaged surgical trays and kits immediately and refrain using them until the FDA can verify their safety. Healthcare providers experiencing problems with the kits are encouraged to file a voluntary report through the FDA’s safety information reporting system, MedWatch.


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