BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing.
Reason for recall: BD has confirmed through internal testing that certain device trays failed routine biocompatibility testing. Distribution: Worldwide - US Nationwide distribution including in the states of AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, LA, MA, MD, MI, MN, MO, MS, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, Singapore, Hong Kong. Quantity: 4180000 units Lot/code info: Catalog Number(s) or Model Number(s): 308341; UDI-DI: 50382903083416; Lot Numbers: 5029670, 5034211, 5041975;
50382903083416
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.