FDA recall Z-3197-2018

Product

ARROW¿ Bipolar Electrode Catheter with shrouded pins , 6 Fr, 110 cm Product Code: AI-06210-S Product Usage: Arrow electrophysiology catheters are intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording

Reason for recall

Products are labeled with an incorrect expiration date

Distribution

US in the state of PA

Key facts

Status

Terminated

Initiation date

2018-07-30

Report date

2018-09-26

Termination date

2019-07-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Reading, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3197-2018