Z-2068-2021Class II

Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm

Name: Z-2068-2021 Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm
Creator: Arrow International Inc
Published: 2021-05-19
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2021-05-19 / Open, Classified

FDA source

Arrow International Inc began a recall of Arrow Pacing Catheter Kit-Bipolar Electrode Catheter 5 Fr. 110 cm, Product Code: AI-05210 - Product Usage: intended for temporary use in electrophysiology... on 2021-05-19. FDA classified it as Class II and gives the reason as "Marketed without a 510K". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2068-2021
Classification: Class II
Status: Open, Classified
Initiated: 2021-05-19
Posted: 2021-07-13
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: 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 code: N/A
Reason for recall: Marketed without a 510K
FDA 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 [email protected] . 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: [email protected]
Quantity in commerce: 48 units
Distribution: US Nationwide distribution in the states of FL, ID, IL, NY, OH, TX.
Product codes and lots: Lot Numbers: 16F16F0057 16F19D0027 16F18B0040 16F19E0157 16F18E0121 16F19F0093 16F18F0058 16F19G0066 16F19C0082

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2068-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2068-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-13
Z-2069-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-13
Z-2070-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-13
Z-2071-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-07-21	2021-07-13

Product code N/A

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)