—#71973

Product

ARROW Edge Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip: 23cm, CSD-15282-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.

FDA product code: MSD — Catheter, Hemodialysis, Implanted
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K040260
Affected lot / code info: Lot# RL7075214, RL6103402, and RL6083025

Why it was recalled

The tips may not have been adequately welded to the catheter body.

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: Arrow International Inc
Address: 2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2008-06-10
Posted by FDA: 2008-09-17
Terminated: 2009-12-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #71973. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.