Arrow International Inc Recall 88120
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.
Arrow International Inc Recall 88120 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-2068-2021 |
Event ID | 88120 |
Event 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. |
Product Type | Devices |
Distribution | US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX. |
Quantity | 48 units |
Recall Reason | Marketed without a 510K |
Device Classification | 20210721 |
Device Code Info | Lot Numbers: 16F16F0057 16F19D0027 16F18B0040 16F19E0157 16F18E0121 16F19F0093 16F18F0058 16F19G0066 16F19C0082 |
Center Classification Date | 20210713 |
Recall Initiation Date | 20210519 |
Recalling Firm | Arrow International Inc |
Initial Notification | Letter |
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