Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2069-2021 — Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

U.S. FDA — Device Enforcement · United States · 2021-05-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2069-2021
Date of alert
2021-05-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Arrow International Inc
Product category
device
Product type
Devices
Reported risk: Marketed without a 510K
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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