FDA Drug recall D-040-2013
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile
- FDA Drug
- Class I
- terminated
- Published 2012-11-14
On 2012-11-14 the FDA classified a Class I recall of Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile by Merit Medical Systems, citing lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-040-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2006-02-24 |
| Published | 2012-11-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Merit Medical Systems |
| Distribution | CT, MD, OH, SC |
Product
Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt Solution, 18 mL Single Dose Bottle, NDC 23731-8100-8, Sterile.
Reason
Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with endotoxins.
Identifiers
| code_info | All convenience kits containing Part Number 8118, all lot numbers. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-040-2013%22
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