FDA-Device2024-02-14Class II
Bubble Sensor (REF: 70105.5720)
Maquet Medical Systems USA
Hazard
The Bubble Sensor optional accessory to the CARDIOHELP-i extracorporeal life support system includes an incorrect UDI Device Identifier (DI) provided with the label attached to the device.
Sold states
AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.
Affected count
274 units (70 US, 204 OUS)
Manufactured in
45 Barbour Pond Dr, Wayne, NJ, United States
Products
Bubble Sensor (REF: 70105.5720)
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1053-2024Don't want to check this manually?
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