Bubble Sensor (REF: 70105.5720)
Reported: February 14, 2024 Initiated: December 28, 2023 #Z-1053-2024
Product Description
Bubble Sensor (REF: 70105.5720)
Reason for Recall
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.
Details
- Recalling Firm
- Maquet Medical Systems USA
- Units Affected
- 274 units (70 US, 204 OUS)
- Distribution
- AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.
- Location
- Wayne, NJ
Frequently Asked Questions
What product was recalled? ▼
Bubble Sensor (REF: 70105.5720). Recalled by Maquet Medical Systems USA. Units affected: 274 units (70 US, 204 OUS).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 14, 2024. Severity: Moderate. Recall number: Z-1053-2024.
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