# FDA recall Z-0185-2024

> **CareFusion 303, Inc.** · Class I · device recall initiated 2023-09-15.

## Product

BD Alaris Syringe Module, REF 8110

## Reason for recall

Alaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated.

## Distribution

Worldwide Distribution: US (nationwide): AK, AL, AR, AS, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MP, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV,	and WY;   OUS (foreign): Canada, Germany, Cuba, Italy, Japan, South Korea, Turkey, United Arab Emirates, Australia, Bahrain, Botswana, Kuwait, Mexico, Netherlands, Philippines, Pakistan, Qatar, South Africa, Singapore, Belgium, Israel, India, New Zealand, Malaysia, Taiwan, Switzerland

## Key facts

- **Recall number:** Z-0185-2024
- **Recalling firm:** CareFusion 303, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-15
- **Report date:** 2023-11-15

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Diego, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0185-2024

## Citation

> AI Analytics. FDA recall Z-0185-2024. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/Z-0185-2024. Source: US FDA. Licensed CC0.

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