Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
Compare with the code on your package — it is the most precise check available.
Category: Eye Drops & Ophthalmic
- Recalling firm
- Merit Medical Systems, Inc
- NDC code
- 23731-8100-8
- Origin
- UT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-040-2013 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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