QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 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 the QUADROX-i Neonatal with integrated arterial filter and VHK 11000 membrane oxygenator due to a potential for blood leakage at the blood inlet connector when using the reducing screw adapter 1/4 x 3/16. This leakage could result in clinically relevant loss of prime before patient connection or blood loss during patient connection. The affected product has UDI 04037691773414 and includes lots 92209374, 92211752, 92215106, 92222131, 92223169, 92228805, 92234286, and 92236876.
The recalled devices were distributed worldwide, including 490 units in the US across Arizona, California, Florida, Iowa, Louisiana, North Carolina, and Texas, as well as to multiple countries including Canada, Mexico, the United Kingdom, Germany, France, and others. The source document does not specify what remedy consumers or healthcare facilities should undertake.
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: 04037691773414; Lots: 92209374, 92211752, 92215106, 92222131, 92223169, 92228805, 92234286, 92236876
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.