Z-0351-2023Class I

Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter...

Name: Z-0351-2023 Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter...
Creator: ARROW INTERNATIONAL Inc.
Published: 2022-10-27
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2022-10-27 / Terminated / root cause: manufacturing process

FDA source

ARROW INTERNATIONAL Inc. began a recall of Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer on 2022-10-27. FDA classified it as Class I and gives the reason as "There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0351-2023
Classification: Class I
Status: Terminated
Initiated: 2022-10-27
Posted: 2022-12-10
Terminated: 2024-10-07
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access Kit and the Arrow Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm issued an "URGENT MEDICAL DEVICE RECALL" to its consignees on 10/27/2022 by FedEx 2-day mail. The notice explained the problem, the risk, and requested the following: "Action list number 1 Medical facilities 1. Immediately check your inventory for product within the scope of this recall. Users should cease use and distribution of affected product and immediately quarantine the affected product. 2. If you have affected product, complete the RECALL ACKNOWLEDGEMENT FORM, Contact Teleflex Customer Service to receive a return goods authorization (RGA) number. 3. Complete and return form even if you do not have affected product. 4. Teleflex (or your local dealer) will issue a credit note upon receipt of the returned affected product. Action list number 2 Distributors 1. Provide this recall notice to all customers who have received affected product. Each customer is then required to complete the Acknowledgement Form (Appendix 1) and return it to you. 2. Immediately check your inventory for affected product. Cease use and distribution of affected product and immediately quarantine the affected product. You may then return all product in scope. 3. Confirm to Teleflex that you have completed the field activity outlined in actions 1 and 2 of this Action List Number 2. Upon completion of your actions, please forward the completed Acknowledgement Form to Teleflex Customer Service at the contact details provided below. Important - Please ensure you only list lot numbers in scope of this recall notice when completing the Acknowledgement Form (Appendix 1). 4. If you have further distributed product outside of your country, please notify Teleflex Customer Service by return email to the email address provided below. Customer Service via Email: [email protected], Customer Service Telephone: 1-866-396-2111, or FAX: 1-855-419-8507. Customer Service hours of operation are 8am-7pm EST.
Quantity in commerce: 80 units
Distribution: US Distributor in states of: FL, GA, KY, OH, PA and WV.
Product codes and lots: UDI/DI 10801902159448, Lot Number 13F22C0349

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0351-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0351-2023	Class I	Terminated	Voluntary: Firm initiated	2022-12-21	2022-12-09
Z-0352-2023	Class I	Terminated	Voluntary: Firm initiated	2022-12-21	2022-12-09

Product code FOZ

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)