Reported Nov 18, 2020 · Terminated
Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monitor blood parameters during…
Maquet Cardiovascular US Sales, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
Blood Monitoring Unit (BMU 40)model no. 701040852 -
- Product Usageis 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 parameterspartial pressure of oxygen (pO2), temperature (TArt and TVen), oxygen saturation (SO2), hemoglobin (Hb) and hematocrit (Hct)
- Lot codes and dates
- Serial numbers
900020229000213490002163900021879000227690002297900020239000213590002164900021889000227790002298900020249000213690002168900021919000227990002302900020299000213790002170900021949000228090002306900020479000214090002172900021959000228190002312900021129000214390002181900021969000228790002313900021239000214490002183900022109000228990002124900021609000218490002212900022939000213390002161900021859000227390002296
- Serial numbers
- Amount recalled
- 51 units
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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