# FDA recall D-040-2013

> **Merit Medical Systems, Inc** · Class I · drug recall initiated 2006-02-24.

## 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.

## Distribution

Connecticut, Maryland, Ohio, and South Carolina.

## Key facts

- **Recall number:** D-040-2013
- **Recalling firm:** Merit Medical Systems, Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2006-02-24
- **Report date:** 2012-11-14
- **Termination date:** 2013-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** South Jordan, UT, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-040-2013

## Citation

> AI Analytics. FDA recall D-040-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-040-2013. Source: US FDA. Licensed CC0.

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