Sol-Millennium Medical Inc.: Syringes with Eccentric Tips labeled as: 1) SOL-M 10ml Eccentric Tip Syringe w/o Needle, Model No. P180010ET, UPC 81001809551; 2) SOL-M 20ml Eccentric Tip Syringe w/o Need

Hazard

Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use.

Details from the source

Reason for recall: Products in distribution were found by FDA to be to be substantially different from the current cleared 510(k)s with a major change or modification to the device s intended use. Distribution: US Nationwide, Czech Republic, Belgium, Portugal, Canada, Saudi Arabia, Netherland, France, Switzerland, Latvia, UK, Spain, Germany, Philippines, Australia, Malaysia, Jamaica, Slovenia, Brazil, Taiwan, Denmark, Sweden, Singapore, Romania, Poland, Barbados, Mexico, Guatemala, Chile, Ireland, Italy, Panama Lot/code info: 1) Model No. P180010ET, Lot Numbers: 4209010; 2) Model No. P180020ET, Lot Numbers: 4209011; 3) Model No. P180060ET, Lot Numbers: 4209009, 4209011;

Source

Official record: FDA (Device enforcement) ↗

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