FDAFDA · Food and drugs·Recall number D-040-2013
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
Published November 14, 2012 · Recall initiated: February 24, 2006
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Merit Medical Systems, Inc
- Distributor
- Connecticut, Maryland, Ohio, and South Carolina.
- Lot
- All convenience kits containing Part Number 8118, all lot numbers.
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States