It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health.
Reason for recall: It has been identified that testing documentation does not support that the syringes can successfully deliver accurate volumes across the full range of their claimed graduated capacity and may pose a risk to patient health. Distribution: Worldwide distribution - US Nationwide and the countries of Canada, Panama, UAE, USVI. Quantity: 5,075,234 syringes Lot/code info: UDI/DI 10080196306183, All lots in the format: 897YYMMXXXX
10080196306183
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.