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Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood paramete...

FDA Device Recall #Z-0443-2021 — Class II — September 30, 2020

Recall Summary

Recall Number Z-0443-2021
Classification Class II — Moderate risk
Date Initiated September 30, 2020
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Maquet Cardiovascular Us Sales, Llc
Location Wayne, NJ
Product Type Devices
Quantity 51 units

Product Description

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 Pattern

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.

Lot / Code Information

Serial numbers 90002022 90002134 90002163 90002187 90002276 90002297 90002023 90002135 90002164 90002188 90002277 90002298 90002024 90002136 90002168 90002191 90002279 90002302 90002029 90002137 90002170 90002194 90002280 90002306 90002047 90002140 90002172 90002195 90002281 90002312 90002112 90002143 90002181 90002196 90002287 90002313 90002123 90002144 90002183 90002210 90002289 90002124 90002160 90002184 90002212 90002293 90002133 90002161 90002185 90002273 90002296

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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