# FDA recall Z-1702-2020

> **Merit Medical Systems, Inc.** · Class II · device recall initiated 2018-07-09.

## Product

ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile Solution, 10.5 ml Applicator, Hi-Lite Orange, NDC 054365-400-12, Cat. No. 260715NS, a component of Vein Tray K12T-10167 - Product Usage: For the preparation of the patient's skin prior to surgery. Helps to reduce bacteria that potentially can cause skin infection.

## Reason for recall

A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.

## Distribution

US Nationwide distribution in the state of IL.  There was no other distribution.

## Key facts

- **Recall number:** Z-1702-2020
- **Recalling firm:** Merit Medical Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-09
- **Report date:** 2020-04-22
- **Termination date:** 2020-04-14

- **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=Z-1702-2020

## Citation

> AI Analytics. FDA recall Z-1702-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-1702-2020. Source: US FDA. Licensed CC0.

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