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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Arrow International, Inc. 7FR 3-Lumen Arrowg+ard Blue Plus(R) Pressure Injectable Central Venous Cat		see related information
Date Posted June 19, 2012
Recall Number Z-1823-2012
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
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Jennifer E. Thompson
610-378-0131 Ext. 3474
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.
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.
 
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