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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow

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 Class 2 Device Recall Arrowsee related information
Date Initiated by FirmNovember 14, 2017
Date PostedMarch 05, 2018
Recall Status1 Terminated 3 on July 15, 2019
Recall NumberZ-1164-2018
Recall Event ID 79342
510(K)NumberK071538 
Product Classification Catheter,intravascular,therapeutic,short-term less than 30 days - Product Code FOZ
ProductPressure Injectable Two- Lumen Central Venous Catheterization Kit with Blue FlexTip, ARROWg+ard Blue PLUS Catheter and Sharps Safety Features. Permits venous access to central circulation.
Code Information ASK-45802-PHMW 13F16K0236
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information ContactKaren Boylan
610-378-0131
Manufacturer Reason
for Recall		Products do not contain the Central Venous Catheter Placement Procedures Note or the Central Line Insertion Checklist, which is a tool intended to guide clinicians in the use of best practices during central line insertions.
FDA Determined
Cause 2		Labeling mix-ups
ActionOn November 16, 2017, an Urgent Medical Device Notification titled "ARROW PSI and Pressure Injectable Multi-Lumen CVC Kits" was issued to customers informing them of the issue, and urging all to take the following actions: 1. Place a copy of this notification and the enclosed Central Line Insertion Checklist with each unit of affected product currently in your inventory. 2. Complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or e-mail to recalls@teleflex.com. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce18,124 total
DistributionNationwide Distribution
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 = FOZ
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