# FDA recall Z-0385-2019

> **CareFusion 303, Inc.** · Class II · device recall initiated 2018-04-20.

## Product

Alaris Infusion Pump administration sets labeled as:  -Infusion Set  Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion,  WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP FITMENT ON PUMP SEGMENT IS OPEN, Fluid path is STERILE and NONPYROGENIC. 12276678 Rev 00    -VersaSafe Infusion Set  Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 2120-0500, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-01104 Rev 00    -SmartSite Infusion Set  Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump REF 2420-0500,WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLAMP WHEN SAFETY CLAMP ON PUMP SEGMENT IS OPEN. FLUID PATH IS STERILE and NON-PYROGENIC. PRODUCT is sterilized by GAMMA IRRADIATION. CareFusion, 630-00952 Rev 01    -Infusion Set  Alaris Pump Module/Medley Pump Module REF 24009-0007T, WARNI

## Reason for recall

Complaints where users were unable to prime the administration set.

## Distribution

Worldwide Distribution - US Nationwide including Guam  International: Canada, Australia, New Zealand, EU, Middel East, South Africa, Okinawa, Saipan, Buenos Aires, Lima, Selangor, Hong Kong, Taiwan, and Budapest

## Key facts

- **Recall number:** Z-0385-2019
- **Recalling firm:** CareFusion 303, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-04-20
- **Report date:** 2018-11-14
- **Termination date:** 2021-02-10

- **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-0385-2019

## Citation

> AI Analytics. FDA recall Z-0385-2019. Retrieved 2026-07-02 from https://api.ai-analytics.org/recall/Z-0385-2019. Source: US FDA. Licensed CC0.

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