# FDA recall Z-0743-2024

> **Smiths Medical Asd Inc** · Class II · device recall initiated 2023-11-10.

## Product

HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List Number MX496HP

## Reason for recall

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, UAE.

## Key facts

- **Recall number:** Z-0743-2024
- **Recalling firm:** Smiths Medical Asd Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-10
- **Report date:** 2024-01-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Dublin, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0743-2024

## Citation

> AI Analytics. FDA recall Z-0743-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0743-2024. Source: US FDA. Licensed CC0.

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