Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Reported: July 21, 2021 Initiated: May 19, 2021 #Z-2068-2021
Product Description
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
Reason for Recall
Marketed without a 510K
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 48 units
- Distribution
- US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.. Recalled by Arrow International Inc. Units affected: 48 units.
Why was this product recalled? ▼
Marketed without a 510K
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 21, 2021. Severity: Moderate. Recall number: Z-2068-2021.
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