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.
Check against the official notice below — it lists the full affected range.
Maquet Cardiovascular is recalling 490 units of the QUADROX-i Neonatal membrane oxygenator (Part Number 701055120) distributed in the United States and multiple countries worldwide. The devices may experience blood leakage at the blood inlet connector when used with a reducing screw adapter, potentially causing loss of prime before connecting to a patient or blood loss during patient connection.
The affected units have UDI 04037691780139 and lot numbers 92212343, 92214685, or 92225187. The recall notice does not specify a remedy or action for affected consumers to take.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: Worldwide Distribution: US (nationwide) to states of: AZ, CA, FL, IA, LA, NC, and TX and countries of: Canada, Argentina, Brazil, Chile, Colombia, Mexico, Uruguay, United Arab Emirates, Belgium, Switzerland, Germany, Egypt, Spain, France, United Kingdom, Ireland, Italy, Lebanon, Netherlands, Pakistan, Portugal, Reunion, Saudi Arabia, Sweden, South Africa, Poland, Serbia, Russia, Turkey, Ukraine, C Quantity: 490 total in US Lot/code info: UDI: 04037691780139; Lots: 92212343, 92214685, 92225187
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.