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U.S. Department of Health and Human Services

Class 2 Device Recall ARROWgard Blue PSI Kit CathGard

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  Class 2 Device Recall ARROWgard Blue PSI Kit CathGard see related information
Date Initiated by Firm August 06, 2019
Create Date September 23, 2019
Recall Status1 Terminated 3 on September 29, 2020
Recall Number Z-2555-2019
Recall Event ID 83593
510(K)Number K011761  
Product Classification Introducer, catheter - Product Code DYB
Product 8.5 Fr. X 10 cm ARROW+gard Blue PSI Kit Cath-Gard for use with 7.5 - 8 Fr.Catheters
Product Code: CDC-29803-1A - Product Usage: The MACTM Two-Lumen Central Venous Access Device with ARROWg+ard Blue¿ permits venous access and catheter introduction to the central circulation. It may be inserted into the jugular, subclavian, or femoral veins. The ARROWg+ard¿ technology is intended to help provide protection against catheter-related infections. Clinical data have not been collected that demonstrate the use of the ARROWg+ard¿ antimicrobial surface in decreasing catheter-related infections for this device. It is not intended to be used as a treatment for existing infections, nor is it indicated for long-term use.
Code Information Lot Number: 13F18H0610
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact SAME
610-378-0131
Manufacturer Reason
for Recall		 Products may contain the incorrect banner card within the kit
FDA Determined
Cause 2		 Packaging process control
Action Arrow International issued notification dated 8/6/19 stating problem, health risk and action to take: If you have affected stock in inventory, immediately discontinue use and quarantine any products with the product codes and lot numbers. 2. Inspect affected products within your control to confirm the product code on the lidstock matches the product code on the banner card of the same kit. Products confirmed to have an incorrect banner card should be returned to Arrow International. Products which properly match should not be returned. 3. If you have product with an incorrect banner card, please complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507 Attn: Customer Service or email to recalls@teleflex.com. This will allow us to document the amount of product you have on hand for return. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products. 4. If you have no affected stock, please complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email to recalls@teleflex.com. Questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in Commerce 520 eaches
Distribution US Nationwide distribution.
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 = DYB and Original Applicant = ARROW INTL., INC.
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