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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow Teleflex

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  Class 2 Device Recall Arrow Teleflex see related information
Date Initiated by Firm January 06, 2021
Create Date February 10, 2021
Recall Status1 Terminated 3 on July 12, 2022
Recall Number Z-1106-2021
Recall Event ID 87092
510(K)Number K993691  
Product Classification Catheter, intravascular, therapeutic, short-term less than 30 days - Product Code FOZ
Product Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the
femoral, jugular, or subclavian veins.
Product Code: CDC-45703-1A
Code Information Lot Code: 13F20E0173
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Beth Trogdon
919-433-4843
Manufacturer Reason
for Recall		 The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not identify the product as a coated ARROWg+ard Blue PLUS (AGB+) antimicrobial catheter which may cause a minor delay during use and placement of a coated catheter in patients with known sensitivity to chlorohexidine, silver sulfadiazine or sulfa could result in an allergic reaction
FDA Determined
Cause 2		 Under Investigation by firm
Action Arrow International issued Urgent Medical Device Correction notification letter on 6th Jan 2021 via FedEx 2-day mail.Letter states reason for recall, health risk and action to take: 1. If you have affected stock in inventory, immediately discontinue use and quarantine any products with the product codes and lot numbers listed above. 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. This will allow us to document your receipt of this letter. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-396-2111.
Quantity in Commerce 1,705 eaches
Distribution US Nationwide
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 = FOZ and Original Applicant = ARROW INTL., INC.
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