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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