—#196703

Product

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

FDA product code: FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K002507, K071538
Affected lot / code info: UDI/DI 10801902159448, Lot Number 13F22C0349

Why it was recalled

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 (FDA determination)

Process design

Action the firm took

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: Recalls@teleflex.com, Customer Service Telephone: 1-866-396-2111, or FAX: 1-855-419-8507. Customer Service hours of operation are 8am-7pm EST.

Recalling firm

Firm: ARROW INTERNATIONAL Inc.
Address: 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437

Distribution

Distribution pattern: US Distributor in states of: FL, GA, KY, OH, PA and WV.

Timeline

Recall initiated: 2022-10-27
Posted by FDA: 2022-12-10
Terminated: 2024-10-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #196703. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.