Reported Nov 14, 2012 · Terminated

Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC…

Merit Medical Systems, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Merit Medical Systems, Inc · 1600 West Merit Pkwy · South Jordan, UT · 84095-2416

Is this the product you have?

  • Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
Lot codes and dates
  • All convenience kits containing Part Number 8118, all lot numbers.
Amount recalled
2470 kits

Where it was sold

Why it was recalled

Stop using this product now

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

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Feb 28, 2013 · Data as of Sep 19, 6:25 PM UTC

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