Class 2 Device Recall Silicone PICC catheter with PASV Valve.

• Date Initiated by Firm: March 05, 2004
• Date Posted: July 28, 2005
• Recall Status: Terminated on February 06, 2006
• Recall Number: Z-1052-05
• Recall Event ID: 31811
• 510(K)Number: K963097
• Product Classification: Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
• Product: PICC Custom Kit GENESIS MEDICAL CENTER, 4.5F Dual Lumen , Catalog #60M120522. UPN M00160M1205221. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, 10 Glens Falls Technical Park, Glens Falls, NY
• Code Information: 898659, 899145
• Recalling Firm/ Manufacturer: Boston Scientific Corporation; 1 Boston Scientific Pl; Natick MA 01760-1536
• For Additional Information Contact: Marie Peters; 508-652-5875
• Manufacturer Reason for Recall: Lumens may have incorrect lumen size marked on them.
• FDA Determined Cause: Other
• Action: Letters dated March 5, 2004 with instructions to return product to Boston Scientific.
• Quantity in Commerce: 44 kits
• Distribution: Nationwide. Medical facilities in CA, GA, IA, IL, ME, MI, MO, NJ, OH, TN TX, UT, WI,
• 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