Recall Z-2957-2020 ยท KFM Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Maquet Cardiovascular Us Sales, Llc
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
| Date | Aug 7, 2020 |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 r |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991864 | ROTAFLOW CENTRIFUGAL PUMP SYSTEM Jostra Medizintechnik AG, Aug 31, 2000 |