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U.S. Department of Health and Human Services

Class 2 Device Recall ARROWgard Blue Plus

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 Class 2 Device Recall ARROWgard Blue Plussee related information
Date Initiated by FirmSeptember 21, 2018
Create DateNovember 14, 2018
Recall Status1 Terminated 3 on September 23, 2020
Recall NumberZ-0468-2019
Recall Event ID 81242
510(K)NumberK993691 
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
ProductArrow AGB+ Multi-Lumen CVC Kit, 7 Fr., 3 Lumen, 20cm catheter length, .025 inch dia. spring-wire guide, Product Code CDC-45703-B1A - Product Usage: The multiple-lumen catheter permits venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. The ARROWg+ard Blue Plus antimicrobial catheter is intended to help provide protection against catheter-related infections. It is not intended to be used as a treatment for existing infections nor is it indicated for long-term use.
Code Information Lot/Batch Numbers: 13F17E0685 13F17F0562 13F17H0141 13F17K0340 13F18B0119 13R17E0685
FEI Number 3015859709
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information ContactCustomer Service
866-396-2111
Manufacturer Reason
for Recall		The products labeling contains inconsistencies. In certain instances, the lidstock, banner card and shipper label state that the Spring Wire Guide (SWG) within is .032 rather than the correct SWG size .025 . For other lots in scope the lidstock correctly states the SWG size .025 however the banner card states the incorrect SWG size .032 .
FDA Determined
Cause 2		Employee error
ActionUrgent Medical Device Notification letters dated 9/21/18 were distributed to customers.
Quantity in Commerce3640
DistributionUS Nationwide distribution in the states of CA, FL, ID, IL, MI, NC, NJ, PA, and WI.
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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