# FDA recall Z-1453-2020

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2020-01-15.

## Product

Monoject 3mL Syringe with Hypodermic Safety Needle, 22G x 1-1/2 . Item Code 11832215 - Product Usage: used for general purpose injection and aspiration of fluids from vials, ampules and parts of the body below the surface of the skin.

## Reason for recall

Non-sterile product was shipped to customers.  Product package is labeled as both "STERILE" and "NON-STERILR" ; the product did not undergo sterilization process and is non-sterile. The usage of a needle that is not sterile could result in infection. Firm is not aware of any reports of patient harm.

## Distribution

Worldwide distributions - US Nationwide distributions in the states of 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, SC, SD, TN, TX, UT, VA, WA, WI, WV, and countries of Canada, Australia, South Africa, Belgium, Germany, Ireland, Portugal Spain, and UK.

## Key facts

- **Recall number:** Z-1453-2020
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-01-15
- **Report date:** 2020-03-18
- **Termination date:** 2020-12-04

- **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-1453-2020

## Citation

> AI Analytics. FDA recall Z-1453-2020. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1453-2020. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*