FDA Alerts Puerto Rican Facilities of Customed Convenience Packs
The FDA has alerted Puerto Rican healthcare providers and facilities not to use Customed’s convenience packs and trays for surgical procedures.
The products — which include exam gloves, absorbent towels, suture bags, surgical table covers and drapes — have not been tested adequately for sterility, safe levels of endotoxin and ethylene oxide, effective performance up to their expiration date and safe package integrity.
“These deficiencies pose a risk of serious adverse health consequences, such as infection and death,” the agency says.
Customed’s manufacturing facilities were inspected by the FDA in July 2014. The company received a warning letter listing the deficiencies on Dec. 9, 2014. — Michael Cipriano