Class 2 Device Recall AutoSuture

• Date Initiated by Firm: June 30, 2005
• Date Posted: August 06, 2005
• Recall Status: Terminated on September 14, 2010
• Recall Number: Z-1096-05
• Recall Event ID: 32569
• 510(K)Number: K902135
• Product Classification: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
• Product: ChemoSite Implantable venous access sytem with printed silicone Catheter and 9 French Introducer Kit Catalog Number: 120066
• Code Information: Lot Numbers: N4G293 N4H139 N4H439 N4J214 N4K53 N4K4245 N4L257 N4M214
• Recalling Firm/ Manufacturer: United States Surgical Corporation; 195 Mcdermott Rd; North Haven CT 06473-3665
• For Additional Information Contact: Lori Seferian; 203-492-8167
• Manufacturer Reason for Recall: The tear away inroducer sheath may have cracked hubs/handles and /or improper peeling of the sheath during use
• FDA Determined Cause: Other
• Action: United States Surgical notified customers by letter dated June 30, 2005 requesting return of the recalled product.
• Quantity in Commerce: 2340 units
• Distribution: Nationwide Foreign: Australia, Canada, Germany,Israel, Uruguay, Chile,
• 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