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

FDA recall notice · announced November 14, 2012 · Merit Medical Systems

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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.

Notes

Distribution: Connecticut, Maryland, Ohio, and South Carolina.
Lot/code information: All convenience kits containing Part Number 8118, all lot numbers.
Quantity: 2470 kits
Status: Terminated
Products in this recall event:
- Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile. (D-040-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.