Merit Convenience Kits containing Cytosol Ophthalmics Balanced Salt… — Class I drug recall D-040-2013
Terminated recall by Merit Medical Systems, Inc, reported 2012-11-14, distributed in CT, MD, OH, SC. Lack of Assurance of Sterility: Procedure kits contain a balanced salt solution that may be contaminated with
| Recall number | D-040-2013 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merit Medical Systems, Inc, South Jordan, UT, United States |
| Recall initiated | 2006-02-24 |
| Classified | 2012-11-06 |
| Reported by FDA | 2012-11-14 |
| Terminated | 2013-02-28 |
| Distributed | CT, MD, OH, SC |
| Quantity | 2,470 kits |
| Reason classes | sterility |
| NDC | 23731-8100-08 |
| Model numbers | 8118 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-040-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.