Device packaging may contain open seals, compromising product sterility.
Reason for recall: Device packaging may contain open seals, compromising product sterility. Distribution: US distribution in AL, CA, CO, DC, FL, GA, IL, LA, MD, MN, MT, NC, NH, NJ, NM, NY, OH OK, PA, RI, TN, TX, UT, VA, VT, WA, and WI OUS distribution to Canada, Japan, and South Africa Quantity: 4640 units in total Lot/code info: Catalog #40430, Lot Numbers 21M3820 and 21L3403 UDI/DI: 30886158012123
30886158012123
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.