Arizant Inc – FDA Warning Letter, Jan 6, 2010

The FDA issued a Warning Letter to Arizant, Inc. following an inspection from November 30, 2009, to January 6, 2010, which found their Bair Hugger Warming Blankets, Bair Paws Patient Adjustable Warming Systems, and Ranger Blood and Fluid Warming Systems to be misbranded.

Violations include: 1. **Failure to report serious injuries within 30 days (21 CFR 803.50(a)(1))**: An instance of a patient suffering 2nd-degree burns in April 2006 was not reported to the FDA within the required timeframe. Arizant's January 20, 2010, response, including the submission of MDRs on January 13, 2010, and an updated procedure, was deemed adequate for this specific violation. 2. **Failure to report device malfunctions likely to cause serious injury within 30 days (21 CFR 803.50(a)(2))**: Five instances of malfunctions, including units catching fire, causing hypothermia, or resulting in patient burns, were not reported within the required timeframe. Arizant's response, including MDR submissions and an updated procedure, was deemed adequate for these specific violations. 3. **Failure to develop, maintain, and implement adequate written MDR procedures (21 CFR 803.17(a