Maquet QUADROX-i Neonatal Membrane Oxygenator Recalled for Blood Leakage Risk
Maquet is recalling QUADROX-i Neonatal membrane oxygenators because a specific reducing screw adapter may cause blood leakage at the inlet connector.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device with a risk of blood loss during surgery, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Maquet Cardiovascular US Sales, LLC is recalling the QUADROX-i Neonatal membrane oxygenator (Part Number 701055120) used in extracorporeal circulation during cardiac surgery. The recall involves 490 units distributed in the United States and internationally.
The recall is due to a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16. This defect may result in clinically relevant loss of prime before patient connection or blood loss during patient connection.
Healthcare facilities and users should stop using the affected devices and contact Maquet Cardiovascular for instructions on return or replacement. The affected lots are 92212343, 92214685, and 92225187.
The recalled product
- Product
- QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in extracorporeal circulation during cardiopulmonary bypass in cardiac surgery.
- Manufacturer
- Maquet Cardiovascular Us Sales, Llc
- Hazard
- Affected units
- 490
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- UDI: 04037691780139
- Lots: 92212343
- 92214685
- 92225187
Distribution
Part of a larger recall action
This product is one of 2 recalled by Maquet Cardiovascular Us Sales, Llc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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