CLASS II Device recall · Reported 18 Nov 2020 · FDA Enforcement Report

Blood Monitoring Unit (BMU recalled by Maquet Cardiovascular Us Sales

Maquet Cardiovascular Us Sales is recalling Blood Monitoring Unit (BMU, distributed nationwide in the US. The recall was initiated on 30 Sep 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSerial 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

Quantity recalled51 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0443-2021
FDA event ID: 86577
Recalling firm: Maquet Cardiovascular Us Sales, Wayne, NJ
Classification: Class II
Status: Terminated
Recall initiated: 30 Sep 2020
FDA classified: 12 Nov 2020
Reported: 18 Nov 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Temperature Abuse
Device type: Patient Monitors

Timeline

30 Sep 2020	Recall initiated by company
12 Nov 2020	Classified by FDA	+43 days
18 Nov 2020	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Foods that need refrigeration and were stored or shipped too warm can grow harmful bacteria without any change in look or smell.

Product as listed by the FDA

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).

Where it was distributed

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.

Nationwide Arizona California Iowa Maryland North Carolina Pennsylvania Texas Washington Wisconsin

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Maquet Cardiovascular Us Sales

All 62

Reported	Class	Recall	Company	Reason	Where
23 Dec 2020Device	CLASS II	HLS Set Advanced recalled by Maquet Cardiovascular Us Sales	Maquet Cardiovascular Us Sales	Sterility	Nationwide
23 Dec 2020Device	CLASS II	HLS Set Advanced recalled by Maquet Cardiovascular Us Sales	Maquet Cardiovascular Us Sales	Sterility	Nationwide
28 Oct 2020Device	CLASS II	Yuno II Mobile Operating Table recalled	Maquet Cardiovascular Us Sales	Foreign Material	Nationwide
28 Oct 2020Device	CLASS II	Yuno Mobile Operating Table recalled by Maquet Cardiovascular Us Sales	Maquet Cardiovascular Us Sales	Foreign Material	Nationwide
23 Sep 2020Device	CLASS III	Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) recalled	Maquet Cardiovascular Us Sales	Other	Nationwide

Other Patient Monitors recalls

All 1,013

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS I	Bravo CF capsule delivery device, Product Number FGS recalled	Given Imaging	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
9 Sep 2026Device	CLASS II	Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled	Boston Scientific	Device Malfunction	Nationwide
2 Sep 2026Device	CLASS II	IQecg Digital ECG recalled by Midmark	Midmark	Labeling Errors	Nationwide