# FDA recall Z-1309-2021

> **CareFusion 303, Inc.** · Class I · device recall initiated 2021-03-03.

## Product

BD Alaris Infusion Pump Module Model 8100 Pump Module Keypad; and Pump Module Door Assembly Replacement Kit with Pump Module Keypad, Parts: 49000239; 49000346; 49000438; 49000439.

## Reason for recall

Pump Module keypad lifting, and Fluid ingress could result in 1) Unresponsive keys: module continues infusion, PC unit will not alarm and must be used for programming changes, may necessitate a different Pump Module. May result in infusion start delay/inability to titrate medication. 2) Stuck keys: PC unit alarms, module exhibits Channel Error, may result in infusion interruption/start delay

## Distribution

Worldwide distribution.  US nationwide and countries of: AE, IL, IN, SA, BE, QA, SG, TW, KW, ZA, PH, AU, HU, NZ

## Key facts

- **Recall number:** Z-1309-2021
- **Recalling firm:** CareFusion 303, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2021-03-03
- **Report date:** 2021-04-07

- **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-1309-2021

## Citation

> AI Analytics. FDA recall Z-1309-2021. Retrieved 2026-07-13 from https://api.ai-analytics.org/recall/Z-1309-2021. Source: US FDA. Licensed CC0.

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