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U.S. Department of Health and Human Services

Class 3 Device Recall ROTAFLOW Centrifugal Pump System

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  Class 3 Device Recall ROTAFLOW Centrifugal Pump System see related information
Date Initiated by Firm August 07, 2020
Create Date September 12, 2020
Recall Status1 Terminated 3 on January 14, 2021
Recall Number Z-2957-2020
Recall Event ID 86209
510(K)Number K991864  
Product Classification Pump, blood, cardiopulmonary bypass, non-roller type - Product Code KFM
Product 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
Code Information Serial Numbers: 94175452 94175453 94175454 94175455 94175460 94175461 94175462 94175515 94175516 94175517 94175518  UDI: 04037691562445
Recalling Firm/
Manufacturer		 Maquet Cardiovascular Us Sales, Llc
45 Barbour Pond Dr
Wayne NJ 07470-2094
For Additional Information Contact SAME
973-709-7000
Manufacturer 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
FDA Determined
Cause 2		 Labeling Change Control
Action Maquet/Getinge issued Urgent Medical Device Correction letter dated August 7, 2020, issued via FedEx 2 day delivery. Letter states reason for recall, health risk and action take: Please examine your inventory immediately to determine if you have a Rotaflow System with a serial number of 94175452 or greater. The serial number tag is on the back of the device (see image below). Please contact your Getinge representative or email IFUrotaflowsystem.cp@getinge.com to request 1 (one) revised IFU/(s). Please supply a mailing address, contact person and phone number on page 4. Please complete and return the form (page 4) to acknowledge this recall by emailing a scanned copy to IFUrotaflowsystem.cp@getinge.com or by faxing the form to 18664771833. A revised IFU will be shipped to you as quickly as possible. In the mantime, please attach a copy of this letter to each copy of the affected IFU. Once you receive the revised IFU, please dispose of the old IFU with the incorrect serial number reference. Qquestions, telephone number +1 973 709 7412 or through email at Rachana.Patel@getinge.com.
Quantity in Commerce 105 total: US: 11 each OUS: 94 each
Distribution 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KFM and Original Applicant = JOSTRA MEDIZINTECHNIK AG
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