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U.S. Department of Health and Human Services

Class 2 Device Recall Arrow International, Inc. 7FR 3Lumen Arrowgard Blue Plus(R) Pressure Injectable Central Venous Cat

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 Class 2 Recall
Arrow International, Inc. 7FR 3Lumen Arrowgard Blue Plus(R) Pressure Injectable Central Venous Cat
see related information
Date Posted June 19, 2012
Recall Status1 Terminated on April 03, 2014
Recall Number Z-1823-2012
Recall Event ID 62125
Premarket Notification
510(K) Number
K071538 
Product Classification Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days - Product Code FOZ
Product Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Catheter - Catalog number CDC-42703-XP1A The multiple-lumen pressure injectable catheter permits venous access to central circulation and injection of contrast media. The ARROWg+ard(R) antimicrobial surface is intended to provide protection against catheter-related infections.
Code Information Lot number RF2033361
Recalling Firm/
Manufacturer
Arrow International Inc
2400 Bernville Road
Reading, Pennsylvania 19605
For Additional Information Contact Jennifer E. Thompson
610-378-0131
Manufacturer Reason
for Recall
Arrow is recalling the product due to the possibility of voids in the catheter hub which could lead to an interlumen crossover.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action Arrow International sent a Urgent Medical Device Recall Notification letter dated June 11, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to take the following action: 1. If you have affected stock, immediately discontinue use and quarantine any products with the catalog and lot numbers listed. 2. To return product complete the enclosed Recall Acknowledgement Form and fax to 1-800-343-2935, Attn: Customer Service. This will allow us to document the amount of the product you have on hand for return. A customer service representative will contact you with a 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 t he enclosed Recall Acknowledgment Form and fax it to 1-800-343-2935, Attn: Customer Service. 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 1-800-343-2935.
Quantity in Commerce 1,085
Distribution USA (nationwide) AL, AZ, AR, CA, CO, FL, GA, IL, IN, KS, LA, MA, MI, MO, NV, NH, NC, OH, PA, TX, VA, WA, and WI.
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 INTERNATIONAL, INC.
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