FDA recall Z-0955-2023

Covidien, LLC · Class II · device

Product

COVIDIEN Emprint Ablation Catheter with Thermosphere Technology, Bronchoscopic Ablation, REF CA108L1

Reason for recall

The product is labeled with the incorrect expiration date.

Distribution

Foreign Distribution: Hong Kong

Key facts

Status
Ongoing
Initiation date
2022-11-23
Report date
2023-01-18
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0955-2023