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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow Arterial Catheterization

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  Class 2 Device Recall Arrow Arterial Catheterization see related information
Date Initiated by Firm October 26, 2017
Create Date April 02, 2018
Recall Status1 Terminated 3 on December 10, 2019
Recall Number Z-1286-2018
Recall Event ID 79314
510(K)Number K810675  
Product Classification cardiovascular catheterization - Product Code DQX
Product Radial Artery Catheterization Kit; Model: AK-04220
Code Information Lots: 13F16H0429, 13F16M0214, 13F17F0281, 23F16H0161, 23F16J0018; Expiration dates: October 2018 through March 2020
Recalling Firm/
Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Amy Malone
Manufacturer Reason
for Recall
The povidone iodine prep pads included in certain kits and trays do not meet the requirements for a 36-month shelf life and should be labeled with a 24-month shelf life.
FDA Determined
Cause 2
Nonconforming Material/Component
Action Teleflex/Arrow sent a letter dated October 26th, 2017. Customers are instructed to discontinue use and quarantine any products with the affected product codes and lot numbers. There is a Recall Acknowledgment Form that is requested to be completed that will allow the return and replacement of the affected product. Consignees without affected product on hand are also asked to return the form.
Quantity in Commerce 6358
Distribution US nationwide distribution, including Puerto Rico.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQX and Original Applicant = ARROW INTL., INC.