# FDA recall Z-0307-2018

> **Smiths Medical ASD Inc.** · Class II · device recall initiated 2017-11-22.

## Product

CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY

## Reason for recall

Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump.

## Distribution

US, Australia

## Key facts

- **Recall number:** Z-0307-2018
- **Recalling firm:** Smiths Medical ASD Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-22
- **Report date:** 2018-01-10
- **Termination date:** 2020-09-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Minneapolis, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0307-2018

## Citation

> AI Analytics. FDA recall Z-0307-2018. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-0307-2018. Source: US FDA. Licensed CC0.

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