# FDA recall Z-2286-2021

> **Cardinal Health** · Class I · device recall initiated 2021-08-04.

## Product

Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125     The proposed device is indicated for use in flushing compatible intravenous tubing systems and indwelling intravascular access devices.

## Reason for recall

Potential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.

## Distribution

US Nationwide Distribution:  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.

## Key facts

- **Recall number:** Z-2286-2021
- **Recalling firm:** Cardinal Health
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-08-04
- **Report date:** 2021-09-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Mansfield, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2286-2021

## Citation

> AI Analytics. FDA recall Z-2286-2021. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-2286-2021. Source: US FDA. Licensed CC0.

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