FDA recall Z-1053-2024

Product

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.

Distribution

AZ, CA, CO, FL, GA, IA, IL, MN, NE, PA, TX, WA and WI.

Key facts

Status

Ongoing

Initiation date

2023-12-28

Report date

2024-02-14

Voluntary/Mandated

Voluntary: Firm initiated

Location

Wayne, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1053-2024