# FDA recall Z-1641-2023

> **Maquet Medical Systems USA** · Class II · device recall initiated 2023-05-18.

## Product

QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass  Model                        Item No. HMO 30000-USA      701070384 HMO 31000-USA      701070388

## Reason for recall

1. An accessory may be improperly placed during packaging, causing creases and damage to the accessory's  sterile pouch.  2. Product packaging may exhibit holes, cracks, dents, and crushed areas.     Both issues may compromise the sterile barrier of the packaging, and exposure to non-sterile product may result in inflammation, infection, sepsis, and ischemia.

## Distribution

Domestic distribution nationwide.

## Key facts

- **Recall number:** Z-1641-2023
- **Recalling firm:** Maquet Medical Systems USA
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-05-18
- **Report date:** 2023-06-07

- **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-1641-2023

## Citation

> AI Analytics. FDA recall Z-1641-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-1641-2023. Source: US FDA. Licensed CC0.

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