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U.S. Department of Health and Human Services

Class 2 Device Recall Arrowgard Blue Plus Antimicrobial Multilumen Central Venous Catheter

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 Class 2 Recall
Arrowgard Blue Plus Antimicrobial Multilumen Central Venous Catheter
see related information
Date Posted April 24, 2014
Recall Status1 Open
Recall Number Z-1507-2014
Recall Event ID 67834
Premarket Notification
510(K) Number
K993691 
Product Classification Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days - Product Code FOZ
Product Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter, catalogue number AK-45854-CDC.
Code Information lot RF2110924
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Road
Reading, Pennsylvania 19605
For Additional Information Contact Customer Support
610-378-0131
Manufacturer Reason
for Recall
Arrow is recalling the Arrowgard Blue Plus Antimicrobial Multi-lumen Central Venous Catheter due to a labeling inconsistency. One portion of the lidstock states that the kit contains 8.5FR x 16CM catheter, while the rest of the lidstock correctly identifies the catheter as 8.5FR x 20CM
FDA Determined
Cause 2
PRODUCTION CONTROLS: Error in Labeling
Action Arrow International Inc, ("Arrow") sent a Urgent Medical Device Recall Notification dated July 17, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog and lot number listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to : 1-866-804-9881. Attn: Customer Service. This will allow us to document the amount of product you have on hand for return Goods Authorization (RGA) number and will provide instructions for the return of product to Arrow International. 3.If you have no affected stock please complete the enclosed Recall Acknowledgement Form and fax it to : 1-866-804-9881, Attn: Customer Service. This will allow us to document your receipt of this letter. For further questions please contact Arrow Customer Service at 1-800-343-2935.
Quantity in Commerce 170
Distribution US Distribution including the states of IA, OR, WV, MI, AZ, IL, PA, GA, DE, NC, LA, and VA.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FOZ and Original Applicant = ARROW INTL., INC.
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