Home / Recalls / Maquet Cardiovascular Us Sales, Llc / Z-0678-2020

Z-0678-2020 Class II Terminated

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

Recall Details

Product Type
Devices
Report Date
December 18, 2019
Initiation Date
December 3, 2019
Termination Date
September 18, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11 distributed in the US

Product Description

Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.

Reason for Recall

A loose ODU plug / Coaxial cable connection may result in fluctuating flow values on the Console.

Distribution Pattern

The products were distributed to the following US states: ME, NV, NY, OH, PA, TX, and VA.

Code Information

UDI: 04037691258997; Serial Numbers 9348936 910114412 910114420 910114429 910114430 910114432 910114435 910114438 910117243 91064722 91067680

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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-0133-2021 Class II — Yuno II Mobile Operating Table - Product Usage: support and position the patient (September 24, 2020)
  • Z-0132-2021 Class II — Yuno Mobile Operating Table - Product Usage: Intended for support and position t (September 24, 2020)
  • 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)