FDA Medical Device Recalls (openFDA)
Arrow International Inc: Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
- Recall number
- Z-2069-2021
- Recalling firm
- Arrow International Inc
- Product
- Arrow Temporary Pacing Catheter/Introducer Kit 6Fr. pacing catheter 7Fr. introducer Product Code: AI-06210-IK - Product Usage: intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.
- Status
- Open, Classified
- Initiated
- 2021-05-19
- Posted
- not on file
- Terminated
- not on file
- Reason
- Marketed without a 510K
- Root cause
- 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
- 5 units
- Distribution
- US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
- Lot, serial or model codes
- Lot Numbers: 16F20C0035 16F20F0124
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- N/A
- Firm FEI
- 3015859709
- Firm city
- Reading
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28