Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Arrowgard Blue Plus Antimicrobial Multilumen Central Venous Catheter see related information
Date Initiated by Firm July 17, 2013
Date Posted April 24, 2014
Recall Status1 Terminated 3 on June 02, 2015
Recall Number Z-1507-2014
Recall Event ID 67834
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 PA 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		 Labeling False and Misleading
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 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.
-
-