Class I
Terminated
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
- Company
- Merit Medical Systems, Inc
- Recall Initiated
- February 24, 2006
- Posted
- November 14, 2012
- Recall Number
- D-040-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2470 kits
- Firm Location
- South Jordan, UT, United States
Reason for Recall
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Distribution
Connecticut, Maryland, Ohio, and South Carolina.
Lot / Code Info
All convenience kits containing Part Number 8118, all lot numbers.
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