# FDA recall Z-2369-2020

> **Resource Optimization & Innovation LLC** · Class II · device recall initiated 2020-05-04.

## Product

Regard SRHS Central Line Kit, Sterile, 20/case - Product Usage: The Saline Flush Syringes are intended to be used only for the flushing of indwelling of vascular access devices.

## Reason for recall

There is a potential for the product to exhibit holes in the packaging, which impacts package integrity and potentially compromises a sterile field.

## Distribution

US Nationwide distribution including in the states of MO, NC.

## Key facts

- **Recall number:** Z-2369-2020
- **Recalling firm:** Resource Optimization & Innovation LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-05-04
- **Report date:** 2020-06-24
- **Termination date:** 2022-09-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Louis, MO, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2369-2020

## Citation

> AI Analytics. FDA recall Z-2369-2020. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2369-2020. Source: US FDA. Licensed CC0.

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