Beaver Visitec International, Inc.: CustomEyes kits

Hazard

Device packaging may contain open seals, compromising product sterility.

Details from the source

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 #BVI-58001086 and BVI-58001089, Lot Numbers 6051841, 6052299, 6051842, 6052300 UDI/DI: 50886158021990 and 50886158021969

UPC codes

50886158021990, 50886158021969

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.