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U.S. Department of Health and Human Services

Class 2 Device Recall ARROW Edge

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  Class 2 Device Recall ARROW Edge see related information
Date Initiated by Firm June 10, 2008
Date Posted September 17, 2008
Recall Status1 Terminated 3 on December 03, 2009
Recall Number Z-2280-2008
Recall Event ID 48706
510(K)Number K040260  
Product Classification Catheter - Product Code MSD
Product ARROW Edge¿ Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to Tip: 50cm, CS-15552-I, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA

The product is used for long term hemodialysis vascular access.
Code Information Lot# RL7034397, RL7013939, RL6062815, RL6062792, RL5121654, RL5090834, RL5080628, and RF5060906
Recalling Firm/
Manufacturer		 Arrow International Inc
2400 Bernville Rd
Reading PA 19605-9607
For Additional Information Contact Jody Cadd
610-378-0131 Ext. 3318
Manufacturer Reason
for Recall		 The tips may not have been adequately welded to the catheter body.
FDA Determined
Cause 2		 Device Design
Action Consignees were notified by letter on/about 06/10/2008. They were instructed to: 1. Cease use and distribution and quarantine all affected product immediately. 2. Contact Arrows Customer Service Department for a Return Authorization Number, enter the number on an enclosed Recall Acknowledgement & Stock Status Form and 3. Immediately fax back the form to Arrow International. All affected product is to be returned to Arrow International. A letter containing the recall information was enclosed for physicians who have implanted catheters. Contact Arrow's Customer Service at 1-800-523-8446 for assistance.
Quantity in Commerce 79248 units (total for all catheters listed)
Distribution U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine
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 = MSD and Original Applicant = ARROW INT'L.
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