Class 2 Device Recall LocatorWand Cover

• Date Initiated by Firm: September 27, 2006
• Date Posted: October 24, 2006
• Recall Status: Terminated on December 30, 2006
• Recall Number: Z-0066-2007
• Recall Event ID: 36466
• 510(K)Number: K942024 K931073 K871132
• Product Classification: Locator-Wand Cover - Product Code MMP
• Product: Locator-Wand Cover that is sold in a shelf carton (unit packaging) separate to the sterile tray containing and identified as PORT-A-CATH II Fluoro-Free, Low Profile Venous Access System, PolyFlow Polyurethane Catheter, 1.9mm O.D. tray. REF 21-4683-24. Contents: Portal with ULTRA-LOCK Connector, Radiopaque PolyFlow polyurethane Catheter with CATH-FINDER Sensor Wire, Locator-Wand cover, Nonvented Luer Cap, 20G PORT-A-CATH needle, 18G Blunt needle, 20G GRIPPER PLUS non-Coring Safety needle, 18G Extra Thin Wall Introducer Needle, 6 Fr introducer, 2 ''J'' Guidewires, Syringes, Vein Pick, Tunneling Tool, 20G 90-degree PORT-A-CATH needle, 3 Point-Lok Sharps Safety Devices, Product Information. EtO Sterilized. Single Use. Deltec, Inc., St. Paul, MN 55112 U.S.A.
• Code Information: Lot number M42880
• Recalling Firm/ Manufacturer: Smiths Medical MD, Inc.; 1265 Grey Fox Rd; Saint Paul MN 55112-6929
• Manufacturer Reason for Recall: Smiths Medical became aware that product returned to them under recall # Z-0800-06/ Z-0807-06 was inadvertently distributed to consignees after the recall was initiated 03/29/2006. The product was originally recalled because Locator Wand covers, which are supplied on the outside of PORT-A-CATH and P.A.S. PORT sterile trays, may have an insufficient seal and product sterility could be compromised.
• FDA Determined Cause: Other
• Action: An Urgent Product Safety & Recall Notification, dated 09/27/06, was sent to customers via facsimile and phone calls were made. The letter describes the issue and customers are given 3 options to include: use only the sterile tray and discard the wand cover, remove and discard Locator-Wand Cover pouches and request replacement Locator-Wand Covers, or return the entire device for a credit or replacement.
• Quantity in Commerce: 1 tray
• Distribution: CA, FL, MA, MD, OH, OK, TX
• 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 = MMP and Original Applicant = DELTEC SYSTEMS, INC.; 510(K)s with Product Code = MMP and Original Applicant = PHARMACIA DELTEC, INC.