Recall Z-3197-2018 ยท DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Arrow International Inc
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
| Date | Jul 30, 2018 |
| Status | Terminated |
| Reason | Products are labeled with an incorrect expiration date |
| Root cause | Error in labeling |
| Action | Arrow International notified US consignee notification by letter on 30 JUL 2018 via FedEx 2-day mail. Account action: immediately discontinue use and quarantine any products with the product codes and lot numbers listed above, so that the affected products can be returned to Arrow. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. |
| Quantity | 7 eaches |
| Distribution | US in the state of PA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K945229 | ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS Arrow Intl., Inc., Aug 8, 1995 |