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U.S. Department of Health and Human Services

Class 1 Device Recall Arrow

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  Class 1 Device Recall Arrow see related information
Date Initiated by Firm August 10, 2023
Date Posted October 05, 2023
Recall Status1 Open3, Classified
Recall Number Z-0003-2024
Recall Event ID 93014
510(K)Number K071538  
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
Product Arrow Pressure Injectable Arrowg+ard Blue Plus¿ Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Code Information Batch/Lot number 13F22L0806
Recalling Firm/
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
Manufacturer Reason
for Recall
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
FDA Determined
Cause 2
Under Investigation by firm
Action 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.
Quantity in Commerce 380 units
Distribution US
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FOZ and Original Applicant = ARROW INTERNATIONAL, INC.