Home / Recalls / Maquet Cardiovascular Us Sales, Llc / Z-0437-2019

Z-0437-2019 Class I Terminated

Recalled by Maquet Cardiovascular Us Sales, Llc — Wayne, NJ

Recall Details

Product Type
Devices
Report Date
December 5, 2018
Initiation Date
October 25, 2018
Termination Date
June 5, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
490 total in US

Product Description

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.

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 Pattern

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.

Code Information

UDI: 04037691773414; Lots: 92209374, 92211752, 92215106, 92222131, 92223169, 92228805, 92234286, 92236876

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