Maquet recalls Quadrox-i Neonatal without integrated arterial filter and VHK 11000 units with potential blood leakage at blood inlet connector using reducing screw adapter 1/4 x 3/16.
There is a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16 that may result in clinically relevant loss of prime before patient connection or blood loss during patient connection.
Maquet is recalling certain Quadrox-i Neonatal without integrated arterial filter and VHK 11000 units due to a risk of blood leakage at the blood inlet connector when using a specific reducing screw adapter. This could lead to clinically significant blood loss during patient connection or loss of prime before patient connection.
The reducing screw adapter 1/4 x 3/16 can cause blood leakage at the blood inlet connector when used with the Quadrox-i Neonatal unit. This leakage may result in clinically relevant blood loss during patient connection or loss of prime before patient connection.
Healthcare professionals using the recalled Quadrox-i Neonatal units with the specific reducing screw adapter 1/4 x 3/16 are most at risk of blood leakage during patient connections.
Check for the Quadrox-i Neonatal without integrated arterial filter and VHK 11000 units with part number 701055120. The units were sold in lots 92212343, 92214685, and 92225187.
Identify units with part number 701055120 from lots 92212343, 92214685, or 92225187.
The reducing screw adapter 1/4 x 3/16 is the specific adapter that can cause blood leakage at the blood inlet connector.
Blood leakage could result in clinically relevant loss of prime before patient connection or blood loss during patient connection.
Check for the Quadrox-i Neonatal without integrated arterial filter and VHK 11000 units with part number 701055120 from lots 92212343, 92214685, or 92225187.
We’ve drafted a message you can send Maquet to request your refund or repair — edit it as you like.
Subject: Recall Z-0436-2019 — Maquet Maquet Hello, I own a Maquet that is covered by recall Z-0436-2019 from Maquet. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
