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Class 2 Device Recall Arrow |
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Date Initiated by Firm |
May 19, 2021 |
Create Date |
July 13, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-2071-2021 |
Recall Event ID |
88120 |
Product Classification |
unknown device name - Product Code N/A
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Product |
Arrow Temporary Pacing Catheter/Introducer Kit 5Fr. pacing catheter 6 Fr. introducer Product Code: AI-07155-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
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Code Information |
Lot Numbers: 23F20A0230 23F20E0004 23F20E0094 |
Recalling Firm/ Manufacturer |
Arrow International Inc 2400 Bernville Rd Reading PA 19605-9607
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For Additional Information Contact |
SAME 610-378-0131
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Manufacturer Reason for Recall |
Marketed without a 510K
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FDA Determined Cause 2 |
No Marketing Application |
Action |
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 |
Quantity in Commerce |
15 units |
Distribution |
US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX. |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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