FDA-Drug2012-11-14Class I

Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.

Merit Medical Systems, Inc
Hazard

Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.

Sold states
Connecticut, Maryland, Ohio, and South Carolina.
Affected count
2470 kits
Manufactured in
1600 West Merit Pkwy, N/A, South Jordan, UT, United States
Products
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-040-2013

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