Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose B...
FDA Recall #D-040-2013 — Class I — February 24, 2006
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.
Recalling Firm
Merit Medical Systems, Inc — South Jordan, UT
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
2470 kits
Distribution
Connecticut, Maryland, Ohio, and South Carolina.
Code Information
All convenience kits containing Part Number 8118, all lot numbers.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated