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

FDA device recall Z-0437-2019 was initiated by Maquet Cardiovascular Us Sales, Llc on October 25, 2018 and is designated Class I. 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… The recall status is terminated (terminated June 5, 2020). Affected quantity: 490 total in US.

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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  • Z-0443-2021 Class II — Blood Monitoring Unit (BMU 40), model no. 701040852 - Product Usage: is to monit (September 30, 2020)
  • Z-0132-2021 Class II — Yuno Mobile Operating Table - Product Usage: Intended for support and position t (September 24, 2020)
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  • Z-2957-2020 Class III — Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instr (August 7, 2020)
  • Z-2780-2020 Class II — Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygen (June 18, 2020)
  • Z-1603-2020 Class II — Avalon Elite Vascular Access Kit, Model No. 70106.3540, UDI 04037691831039 (February 20, 2020)
  • Z-1475-2020 Class II — Getinge 88-Series-washer disinfectors intended for cleaning, disinfection and dr (February 10, 2020)
  • Z-1390-2020 Class III — Getinge 46-Series Washer Disinfector Model # 46-4, Part Number:46-4-502 Product (January 16, 2020)

FDA data resources