Arrow Bipolar Balloon Electrode Catheter 5 Fr. 105 cm, Product Code: AI-07154 - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
- Company
- Arrow International Inc
- Recall Initiated
- May 19, 2021
- Recall Number
- Z-2070-2021
- Quantity
- 4 units
- Firm Location
- Reading, PA
Reason for Recall
Marketed without a 510K
Distribution
US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
Lot / Code Info
Lot Numbers: 16F19J0109
Root Cause
No Marketing Application
Action Taken
Teleflex issued Urgent Medical Device Device Recall Letter (EIF-000470) on 19th May 2021 via FedEx 2-day mail. The letter states reason for recall, health risk and action to take: Action list number 1 Medical facilities 1. We request that you check your inventory for product within the scope of this FSCA. Users should cease use and distribution of impacted product and quarantine immediately. 2. If you do not have stock in scope of this FSCA mark the according checkbox on the Acknowledgement Form (Appendix 1) and return the form to the fax number or e-Mail address mentioned below. 3. If you do have stock in scope of this FSCA, complete the Acknowledgement Form (Appendix 1 and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com . This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions for the return of products to Teleflex Medical. Action list number 2 Distributors 1. Provide this field safety notice to all customers who have received product in scope of this FSCA. Your customer is then required to complete the acknowledgement form and return to you. 2. We request that you check your inventory for product within the scope of this FSCA. Cease use lreleflex ARROW. 11-TERNATIONAL and distribution of impacted product and quarantine immediately. You may then return all product in scope. 3. As a distributor, you are then required to confirm to Teleflex that you have completed the field activity outlined above. Upon completion of your actions, please forward the completed Acknowledgement Form to Customer Service. 4. If you have further distributed product outside of your country, please notify Teleflex by return email to the e-Mail address below Customer Service: Contact: Customer Service Telephone: 1-866-396-2111 FAX: 1-855-419-8507 Email: Recalls@teleflex.com