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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 Catheterizationsee related information
Date Initiated by FirmOctober 26, 2017
Create DateApril 02, 2018
Recall Status1 Terminated 3 on December 10, 2019
Recall NumberZ-1286-2018
Recall Event ID 79314
510(K)NumberK810675 
Product Classification cardiovascular catheterization - Product Code DQX
ProductRadial Artery Catheterization Kit; Model: AK-04220
Code Information Lots: 13F16H0429, 13F16M0214, 13F17F0281, 23F16H0161, 23F16J0018; Expiration dates: October 2018 through March 2020
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information ContactAmy Malone
919-621-2311
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
ActionTeleflex/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 Commerce6358
DistributionUS nationwide distribution, including Puerto Rico.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQX
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