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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow MultiLumen Central Venous Catheterization

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  Class 2 Device Recall Arrow MultiLumen Central Venous Catheterization see related information
Date Initiated by Firm September 18, 2014
Date Posted October 16, 2014
Recall Status1 Terminated 3 on December 02, 2014
Recall Number Z-0076-2015
Recall Event ID 69290
510(K)Number K862056  
Product Classification Catheter, percutaneous - Product Code DQY
Product Multi-Lumen Central Venous Catheterization
Kit
Code Information Catolog No - AK-12703 lot number RF3039028
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 International, Inc. has initiated a voluntary recall for product code AK- 12703, lot number RF3039028 because the label on the outer corrugate is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date.
FDA Determined
Cause 2		 Labeling False and Misleading
Action Arrow International sent an Medical Device Advisory Notifications letter dated September 18, 2014, sent to direct accounts to notify them about the product, problem, and actions to be taken. Arrow International, Inc. (Arrow) is notifying customers that the label on the outer corrugate for the above mentioned product code and lot number is labeled with the incorrect expiration date. All kits packaged within the corrugate are correctly labeled. There is no risk to the patient as the kits within the corrugate are labeled with the correct expiration date. Arrow International, Inc. is committed to providing high quality, safe and effective products. We sincerely apologize for any inconvenience this action may cause your operations. If you have any other questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.
Quantity in Commerce 65
Distribution US Distribution including the states of MD, NC , LA , IN , OH, KY, CA , PA , NY and NV.
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 = DQY and Original Applicant = ARROW INTL., INC.
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