Class II — Maquet Cardiovascular Us Sales, Llc
| Recalling firm | Maquet Cardiovascular LLC |
|---|---|
| Registered facility | View this company's 2 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | 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. |
| 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). |
| Quantity | 51 units |
| 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, … |
| Initiated | 2020-09-30 |
| Classified | 2020-11-12 |
| Terminated | 2023-05-25 |
| Recall number | Z-0443-2021 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Maquet Cardiovascular Us Sales, Llc (Z-0443-2021).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86577/
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