Blood Monitoring Unit — Class II medical device recall Z-0443-2021
Terminated recall by Maquet Cardiovascular Us Sales, Llc, reported 2020-11-18, distributed nationwide. The Printed Circuit Board Assembly (PCBA) are not in compliance with the IEC standard (60601 1, third edition)
| Recall number | Z-0443-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Maquet Cardiovascular Us Sales, Llc, Wayne, NJ, United States |
| Recall initiated | 2020-09-30 |
| Classified | 2020-11-12 |
| Reported by FDA | 2020-11-18 |
| Terminated | 2023-05-25 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AU, BE, BR, CA, CH, CL, CN, CZ, DE, EC, ES, FI, FR, GB, HK, IE, IN, IQ, IR, IT, JO, MT, MY, NL, NO, PE, PK, PL, RU, SA, SE, SG, TH, TR, VE, ZA |
| Quantity | 51 units |
| Serial numbers | 90002022, 90002023, 90002024, 90002029, 90002047, 90002112, 90002123, 90002124, 90002133, 90002134, 90002135, 90002136, 90002137, 90002140, 90002143, 90002144, 90002160, 90002161, 90002163, 90002164, 90002168, 90002170, 90002172, 90002181, 90002183 and 26 more |
| Model numbers | 701040852 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0443-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.