# FDA recall Z-1643-2023

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

## Product

QUADROX-iR, used during cardiopulmonary bypass  Model                                  Item No.        Description BEQ-HMO 51100-USA      701067936     Small Adult with filter, with BIOLINE Coating BEQ-HMO 71100-USA      701067880     Adult with filter, with BIOLINE Coating HMO 50100-USA               701067934     Small Adult without filter, with SOFTLINE Coating HMO 51100-USA               701067938     Small Adult with filter, with SOFTLINE Coating HMO 70100-USA               701067874     Adult without filter, with SOFTLINE Coating HMO 71100-USA               701067886     Adult with filter, with SOFTLINE Coating

## 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-1643-2023
- **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-1643-2023

## Citation

> AI Analytics. FDA recall Z-1643-2023. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1643-2023. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*