CBP Determines U.S. and China to be Country of Origin for Catheter Trays
CBP determined that Foley catheter trays originate in the U.S. and China for government procurement “buy American” purposes, the agency said in a notice. The ruling came in response to a request from Medline, which developed the trays and "is considering selling to the U.S. Government in an unspecified procurement tender", said CBP. The "sterilized, single-use trays contain a catheter and all of the equipment necessary to insert the catheter, the ruling said. The equipment and catheter are "organized and sequenced in a way to minimize the possibility of infection," it said.
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While there are multiple models being considered, the company provided a sample latex model of the Foley catheter tray that includes "patient drapes, hand sanitizer, sterile gloves, a syringe prefilled with sterile water to inflate the catheter balloon, lubricating jelly, iodine swabsticks, a syringe to draw a urine sample, securement devices, and a specimen jar," said CBP. For the latex tray, the specimen container, catheter Foley silver, gloves, and drainage bag are manufactured in China and the other materials are of U.S. origin, it said. The latex tray catheters are manufactured in China, though other models are sourced from elsewhere. The catheters in all models are connected to drainage bags by "specially trained technicians" and packaged in Mexico, it said. Medline asserted that attaching the drain bag is a fundamental characteristic and transforms the components into an assembly.
CBP disagreed and said "the operations carried out by Medline in Mexico on the imported components do not result in a substantial transformation of the items into a product of Mexico." As a result, the origin of each item in the set will be where it was manufactured, which, in the case of the latex model, would mean the finished product is a product of China and the U.S., said CBP. The country of origin for the other models of latex trays would be determined in the same way, it said.
(Federal Register 07/08/14)