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U.S. Department of Health and Human Services

Class 2 Device Recall Arrowgard Blue and Arrowgard Blue

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 Class 2 Recall
Arrowgard Blue and Arrowgard Blue
see related information
Date Posted May 19, 2014
Recall Status1 Open
Recall Number Z-1633-2014
Recall Event ID 67833
Premarket Notification
510(K) Number
K071538 
Product Classification Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days - Product Code FOZ
Product Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.
Code Information MF2016829 RM2072044 RM2034076 RM2095792 RM2056629 RM3015571 RM2069733
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
The labeling states that the kit contains Introducer Needle: Echogenic 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe; however, the kit contains, and should state, Introducer Needle: 18 Ga. x 2.5 (6.35cm) XTW and 5mL ArroW Raulerson Spring-Wire Introduction Syringe. As a result of this labeling inconsistency, if the clinician were to place the needle under x-r
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Arrow sent an Urgent Medical Device Recall Notification letter dated July 17, 2013, was sent to the customer requesting they discontinue use and quarantine any remaining affected product for return to Arrow. Our records indicate that you have received products that are subject to this voluntary recall. We are now asking that you take the following actions: 1. If you have affected stock, immediately discontinue use and quarantine any products with the product and lot numbers listed above. 2. To return product, complete the enclosed Recall Acknowledgement Form and fax it to 1-800-343-2935, Attn: Customer Service. This will allow us to document the amount of product you have on hand for return. Your sales representative will contact you with a Return Goods Authorization (RGA) Number and will provide instructions and assistance for the return of product to Arrow International. 3. If you have no affected stock, please complete the 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.
Quantity in Commerce 4285
Distribution US Distribution only to MI.
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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