# FDA recall Z-0443-2021

> **Maquet Cardiovascular Us Sales, Llc** · Class II · device recall initiated 2020-09-30.

## Product

Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during cardiopulmonary bypass (CPB) or similar procedures with extracorporeal circulation, which require continuous monitoring of the arterial and/or venous blood parameters: partial pressure of oxygen (pO2), temperature (TArt and TVen), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct).

## Reason for recall

The Printed Circuit Board Assembly  (PCBA) are not in compliance with the IEC standard (60601 1, third edition). The BMU 40 units affected by this recall were designed with a short creepage distance of 1.8 mm between the two distinct and proximal areas on the printed  circuit board (PCB) where as the standard requires a creepage distance of 4 mm.

## Distribution

Worldwide distribution - US Nationwide distribution including in the states of AZ, CA, IA, MD, NC, PA, TX, WA, WI and the countries of Australia, Belgium, Brazil, Canada, Chile, China, Czech Republic, Ecuador, Finland, France,  Germany, Hong Kong, India, Iran, Iraq, Ireland, Italy, Jordan, Malaysia, Malta, Netherlands, Norway, Pakistan, Peru, Poland, Russia, Saudi Arabia, Singapore, South Africa, Spain, Sweden,  Switzerland, Syria, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela.

## Key facts

- **Recall number:** Z-0443-2021
- **Recalling firm:** Maquet Cardiovascular Us Sales, Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-09-30
- **Report date:** 2020-11-18
- **Termination date:** 2023-05-25

- **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-0443-2021

## Citation

> AI Analytics. FDA recall Z-0443-2021. Retrieved 2026-08-12 from https://api.ai-analytics.org/recall/Z-0443-2021. Source: US FDA. Licensed CC0.

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