Maquet Medical Systems USA recalls Bubble Sensor (REF: 70105.5720)
- Recall date
- December 28, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1053-2024
- FDA classification
- Class II
- Brand / firm
- Maquet Medical Systems USA
- Sold / distributed
- AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Bubble Sensor (REF: 70105.5720)
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