# FDA recall Z-2402-2024

> **B. Braun Medical, Inc.** · Class II · device recall initiated 2024-06-17.

## Product

Outlook OUTLOOK PUMP SET,3 CARESITE LADS,115 IN. Used with an electrically-powered infusion pump for intravenous (IV) administration of medication    Model/ Catalog Number:  490361

## Reason for recall

Potential for the backcheck valve to malfunction, resulting in backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime, resulting in patient injuries of adverse drug reaction and/or product  malfunction with loss of medication/blood.

## Distribution

Worldwide distribution - US Nationwide and the country of Canada.

## Key facts

- **Recall number:** Z-2402-2024
- **Recalling firm:** B. Braun Medical, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-17
- **Report date:** 2024-07-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Allentown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2402-2024

## Citation

> AI Analytics. FDA recall Z-2402-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/Z-2402-2024. Source: US FDA. Licensed CC0.

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