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U.S. Department of Health and Human Services

Class 2 Device Recall ARROW Antimicrobial/Antithrombogenic PICC Kits

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  Class 2 Device Recall ARROW Antimicrobial/Antithrombogenic PICC Kits see related information
Date Initiated by Firm March 03, 2017
Date Posted March 08, 2017
Recall Status1 Terminated 3 on February 27, 2018
Recall Number Z-1705-2017
Recall Event ID 76637
510(K)Number K112896  
Product Classification Catheter,intravascular,therapeutic,long-term greater than 30 days - Product Code LJS
Product The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
Code Information Device Listing Number: D149129 Lot Numbers: 23F16C0851, 23F16A0727 and 23F16C0844
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact
866-246-6990
Manufacturer Reason
for Recall		 Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844.
FDA Determined
Cause 2		 Under Investigation by firm
Action Arrow International mailed an Urgent Medical Device Recall Notification letter to affected customers on March 7, 2017, to inform them of the issue. The notification informs customers to discontinue use and quarantine any products identified with the specific lot numbers. Customers are asked to complete the enclosed Recall Acknowledgement Form for product return. For further questions, please call (866) 246-6990.
Quantity in Commerce 1,351 catheters
Distribution US 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 = LJS and Original Applicant = ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.)
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