FDA Warns Puerto Rican Health Providers About Customed Packs

Health care staffers should not use the company's convenience packs and trays for any surgical procedure because adequate testing hasn't been completed, according to the agency.

The U.S. Food and Drug Administration has posted a warning to staffers working at health care facilities or hospitals in Puerto Rico that they should not be using Customed surgical convenience packs and trays for any surgical procedure, including general hospital, dental, and obstetrical and gynecological procedures, because the integrity and safety of their contents -- such as exam gloves, absorbent towels, suture bags, surgical table covers, and drapes -- cannot be assured because adequate testing has not been completed.

Edwin Ramos, director of the Compliance Branch in FDA's San Juan District Office, sent a Warning Letter on Dec. 9, 2014, telling Customed's president and owner that FDA's mid-2014 inspection turned up problems and the company's responses to them were unsatisfactory. FDA reports that the sterility of the company's products is in question, and it cannot prove that endotoxin and ethylene oxide levels are within safe limits, that package integrity can withstand stresses during transport, and that the products will be effective up to their expiration dates.

"These deficiencies pose a risk of serious adverse health consequences, such as infection and death," according to the agency.

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