Class 2 Device Recall Premicath 28G

• Date Initiated by Firm: June 27, 2005
• Date Posted: October 28, 2005
• Recall Status: Terminated on October 31, 2005
• Recall Number: Z-0090-06
• Recall Event ID: 32997
• 510(K)Number: K041468
• Product Classification: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
• Product: Premicath 28G PICC Catheter
• Code Information: Lot numbers 014434 and 012615
• Recalling Firm/ Manufacturer: Vygon Corporation; 2495 General Armistead Ave; Norristown PA 19403
• For Additional Information Contact: Courtney Smith; 610-630-3350
• Manufacturer Reason for Recall: Guidewire protuding from tip of the catheter
• FDA Determined Cause: Other
• Action: The recalling firm issued a recall letter via fax to the distributors on 6/27/05. The letter informed the distributors of the problem and to notify any hospital accounts of the problem and the need to trim the catheter prior to implantation.
• Quantity in Commerce: 243 units
• Distribution: The product was shipped to distributors in CA, CO, FL, IL, MD, NJ, NY, OH, PA, TX and WA.
• 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 = LJS