FDA recall Z-0311-2025

Product

MEGA 7.5Fr. 40cc Intra-Aortic Balloon with Accessories, Model Number 0684-00- 0295-01

Reason for recall

There is discrepant labeling on the inner and outer packaging of the device.

Distribution

International distribution to the countries of Germany, Spain , Finland, Great Britain, Hong Kong, Ireland, Italy, Lithuania, Moldova, Mexico, Norway, New Zealand, Poland, Sweden, Singapore.

Key facts

Status

Ongoing

Initiation date

2024-09-17

Report date

2024-11-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

Fairfield, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0311-2025