FDA recall D-040-2013

Merit Medical Systems, Inc · Class I · drug

Product

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

Reason for recall

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

Distribution

Connecticut, Maryland, Ohio, and South Carolina.

Key facts

Status
Terminated
Initiation date
2006-02-24
Report date
2012-11-14
Termination date
2013-02-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
South Jordan, UT, United States

Primary source

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