There are no directions for use or warning statements on the blister package, the expiration date is not visible at the point of purchase and the packaged product does not conspicuously provide the name and address of the manufacturer, repacker or distributor. Sigma Diagnostics, St. Louis, Missouri. Manufacturer, by letter February 5, 1990. Firm-initiated recall ongoing. Nationwide and international.
Firm estimates none remains on the market.
Manufacturer, by letter February 5, 1990. Firm-initiated recall ongoing. Nationwide and international. Both controls were found either at or below the lower specified values. Omni-Flow I.V. Pump, Model 4000.