FDA WARNING_LETTER - Kimberly-Clark Corporation

The FDA issued a Warning Letter to Kimberly-Clark Corporation regarding its KIMGUARD ONE-STEP Simultaneous and KIMGUARD Sequential Sterilization Wraps. The Center for Devices and Radiological Health (CDRH) determined that significant changes were made to devices previously cleared under K803294 and K881471, necessitating new 510(k) submissions. These changes included modifications to device construction (e.g., two-layer to three-layer), altered tensile strength specifications (both lower and higher), and a new ultrasonic bonding method for simultaneous wraps. The FDA expressed concern that these changes could affect sterilant penetration or maintenance of sterility, impacting device safety and efficacy. Consequently, Kimberly-Clark is in violation of the law for failing to obtain marketing approval or clearance for these modified devices. The devices are deemed adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. 351(f)(1)(B)) due to the absence of an approved PMA or IDE, and misbranded under section 502(o) (21 U.S.C. 352(o)) for not notifying the agency of intent to introduce the devices into commercial distribution as required by section 510(k) (21 U.S.C. 360(k)). The company must take prompt corrective action and respond within fifteen working days, outlining steps taken and prevention plans, or face potential regulatory actions including seizure, injunction, and civil money penalties.