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U.S. Department of Health and Human Services

Class 2 Device Recall The Arrow SingleLumen Catheter

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 Class 2 Device Recall The Arrow SingleLumen Cathetersee related information
Date Initiated by FirmDecember 22, 2017
Create DateApril 10, 2018
Recall Status1 Terminated 3 on May 27, 2020
Recall NumberZ-1331-2018
Recall Event ID 79512
510(K)NumberK820009 
Product Classification Catheter, percutaneous - Product Code DQY
Product(1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP
Code Information Lot Numbers: (1) 13F17D0048; (2) 13F17E0659; (3) 13F17A0075, 13F17C0503, 13F17D0296, 13F17E0541, 13F17F0220, 13F17G0002
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information ContactElizabeth Norwood
919-433-4871
Manufacturer Reason
for Recall		Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
FDA Determined
Cause 2		Process control
ActionThe notification letter includes the following instructions for CUSTOMERS: 1. Discontinue use and quarantine any affected products. 2. Complete and return the Recall Acknowledgement Form to start return process. 3. Complete the Recall Acknowledgment Form if there is no product on hand. Instructions for DISTRIBUTORS: 1.Discontinue distribution and quarantine any affected products. 2. Communicate this recall to any customers with affected product. 3. Have the customers return any affected product to you with a completed Recall Acknowledgement Form. 4. Return affected products from inventory using the Recall Acknowledgement Form. 5. Once you have returned recalled products from your own inventory, and collected the recalled products from your customers, please check the box on the enclosed Recall Acknowledgment Form that indicates that you have completed the recall and return the form.
DistributionDistributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
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 = DQY
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