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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