# FDA recall Z-0709-2024

> **Maquet Cardiovascular, LLC** · Class I · device recall initiated 2023-12-13.

## Product

Product REF 4000-100N, DRAIN, EXPRESS SINGLE W/AC, Single Collection

## Reason for recall

Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards include but are not limited to infection, abscess, sepsis, and death.

## Distribution

Worldwide distribution: US (nationwide) and OUS (Foreign) to countries of: Australia, Brazil, Canada, Luxembourg, Netherlands, Norway, Spain and UK

## Key facts

- **Recall number:** Z-0709-2024
- **Recalling firm:** Maquet Cardiovascular, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-13
- **Report date:** 2024-01-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Wayne, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0709-2024

## Citation

> AI Analytics. FDA recall Z-0709-2024. Retrieved 2026-07-20 from https://api.ai-analytics.org/recall/Z-0709-2024. Source: US FDA. Licensed CC0.

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