Merit Medical Systems, Inc recalls Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8
Recalled November 14, 2012 · FDA recall D-040-2013 · Merit Medical Systems
Hazard
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins. · FDA Class I
Units
2470 kits
Sold at
Connecticut, Maryland, Ohio, and South Carolina.
Description
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Product
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
Manufacturer(s)
Merit Medical Systems, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →