Home / Recalls / Maquet Cardiovascular Us Sales, Llc / Z-2957-2020

Z-2957-2020 Class III Terminated

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

Recall Details

Product Type
Devices
Report Date
September 23, 2020
Initiation Date
August 7, 2020
Termination Date
January 14, 2021
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
105 total: US: 11 each OUS: 94 each

Product Description

Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit Material Number: 701043292

Reason for Recall

Instruction For Use (IFU) references incorrect serial number of 90437000. It should state This document applies to ROTAFLOW Consoles as of serial number 94175452 affected by the implementation of the new IEC standard 60601 1 2, 4th edition

Distribution Pattern

Worldwide distribution - US Nationwide distribution including in the states of ME, NY, NV, OH, TX, VA, WA and the countries of China, Colombia, India, Italy, Mexico, Singapore, South Korea, Spain, Taiwan, Thailand, Turkey, United Arabic Emirates, United Kingdom.

Code Information

Serial Numbers: 94175452 94175453 94175454 94175455 94175460 94175461 94175462 94175515 94175516 94175517 94175518 UDI: 04037691562445

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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)
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  • 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)
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