Reported Sep 23, 2020 · Terminated
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump…
Maquet Cardiovascular US Sales, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Maquet Cardiovascular Us Sales, Llc · 45 Barbour Pond Dr · Wayne, NJ · 07470-2094
Is this the product you have?
- Maquet/Getinge Rotaflow System Console
- US (115 V / 60 Hz) - Product UsageInstructions 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 Number701043292
- Lot codes and dates
- Serial Numbers
9417545294175453941754549417545594175460941754619417546294175515941755169417551794175518
- UDI04037691562445
- Serial Numbers
- Amount recalled
- 105 total: US: 11 each OUS: 94 each
Where it was sold
Why it was recalled
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
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Maquet Cardiovascular US Sales, LLC recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.