Increased rate of out-of-specification endotoxin results.
Reason for recall: Increased rate of out-of-specification endotoxin results. Distribution: US Nationwide distribution in the states of AL, AZ, CA, DC, FL, GA, IA, IL, KS, KY, LA, MD, ME, MN, MO, MT, NC, ND, NE, NJ, NY, OH, PA, SC, SD, TN, TX, VA, VT, WA, WI, WV. Quantity: 46 units Lot/code info: Product ID: WSM0710. UDI-DI: 00386190001448. Lot Numbers: 7579683, 7582225, 7583893, 7582227, 7583933, 7583891, 7591942, 7591944, 7583935, 7594266, 7594288, 7594286, 7593011, 7594284, 7593013.
00386190001448
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.