Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
Reason for recall: Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces. Distribution: The product was distributed to the following US states: Nevada, Colorado, Texas, Washington, Indiana, Georgia, Michigan, Florida, Pennsylvania, Illinois, Tennessee, Virginia, Missouri, South Dakota, California, Montana, Minnesota, Arizona Quantity: 100 units Lot/code info: Lot Code: UDI 10889981216368 Lot Numbers TT0190H, TT0191H
10889981216368
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.