Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
Reported: November 14, 2012 Initiated: February 24, 2006 #D-040-2013
Product Description
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.
Details
- Recalling Firm
- Merit Medical Systems, Inc
- Units Affected
- 2470 kits
- Distribution
- Connecticut, Maryland, Ohio, and South Carolina.
- Location
- South Jordan, UT
Frequently Asked Questions
What product was recalled? ▼
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.. Recalled by Merit Medical Systems, Inc. Units affected: 2470 kits.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 14, 2012. Severity: Critical. Recall number: D-040-2013.
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