Merit Medical Systems Recalls Cytosol Ophthalmics Balanced Salt Solution Kits
Merit Medical Systems is recalling Cytosol Ophthalmics Balanced Salt Solution kits due to a lack of assurance of sterility and potential endotoxin contamination.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric.
Plain-English summary
Merit Medical Systems, Inc. is recalling 2,470 Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile. The recall affects all convenience kits containing Part Number 8118, across all lot numbers.
The recall was initiated due to a lack of assurance of sterility. The procedure kits contain a balanced salt solution that may be contaminated with endotoxins. The affected products were distributed in Connecticut, Maryland, Ohio, and South Carolina.
Consumers and healthcare providers should stop using the affected kits and contact Merit Medical Systems for further instructions or a replacement.
The recalled product
- Product
- Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
- Manufacturer
- Merit Medical Systems, Inc
- Affected units
- 2,470
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All convenience kits containing Part Number 8118
- all lot numbers.
Distribution
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