Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Recall
- Recall Number
- Z-0003-2024
- Event Number
- 93014
- Firm
- ARROW INTERNATIONAL Inc.
- FEI Number
- 3013162291
- Product Code
- FOZ
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- August 10, 2023
- Posted
- October 5, 2023
- Address
- 3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437
Description
Arrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
Teleflex/Arrow International issue an URGENT MEDICAL DEVICE RECALL notice on 08/10/2023 by FedEx 2nd day mail. The letter explained the problem, risk to patient, and requested the following actions: Medical facilities: Immediately cease use and distribution of affected product and quarantine for return. Distributors: Immediately cease use and distribution of affected product and quarantine for return. Provide a copy of this recall notice to all customers who have received impacted product. Request they complete the Acknowledgement Form and return it to you. Firm is requesting return of the affected product.
US
380 units