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Maquet Cardiovascular Us Sales, Llc recalls QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Num
Recalled December 5, 2018 · FDA recall Z-0436-2019 · Maquet Cardiovascular Us Sales
Hazard
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. · FDA Class I
Units
490 total in US
Sold at
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, China, India, Japan, Republic of Korea (South Korea), Malaysia, Thailand, and Taiwan.
Description
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.
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(s)
Maquet Cardiovascular Us Sales, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →