Class 1 Device Recall Vaxcel

• Date Initiated by Firm: May 13, 2010
• Date Posted: July 01, 2010
• Recall Status: Terminated on August 03, 2012
• Recall Number: Z-1876-2010
• Recall Event ID: 55786
• 510(K)Number: K030083 K032008
• Product Classification: port & catheter, implanted, subcutaneous, intravascular - Product Code LJT
• Product: Navilyst Medical, Inc., Vaxcel(TM) Port with PASV(TM) Titanium Mini-Port with PASV Valve and 8F Silicone Catheter (1.4 mm/2.6 mm), REF Catalog No. 45-220, UPN Product No. M001452200, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System with PASV(TM) Valve Technology --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
• Code Information: Lots 1193953, 1195311, 1198104, 1200700, 1202457, 1204614, 1207340, 1207664, 1214355, 1214650, 1215657, 1216850, 1221191, 1227000, 1228413, 1231143, 1232464, 1235320, 1239041, 1239321, 1240899, 1244264, 1247038, 1248432, 1250527, 1252585, 1257023, 1258103, 1263712, 1265771, 1267691, 1273901, 1277633, 1281030, 1285145, 1288649, 1294480, 1295865, 1296141, 1296709, 1297923, 1300521, 1307356, 1307357, 1307358, 1311034, 1313096, 1313097, 1348374, 1353274, 1355601, 1356197, 1365529, 1367037, 1368843, 1370103, 1372521, 1374541, 1377316, 1377612, 1377844, 1378093, 1378345, 1380085, 1381887, 4000284, 4001732, 4007724, 4014661
• Recalling Firm/ Manufacturer: Navilyst Medical, Inc; 10 Glens Falls Technical Park; Glens Falls NY 12801
• For Additional Information Contact: Michael Duerr; 518-742-4412
• Manufacturer Reason for Recall: FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.
• FDA Determined Cause: Nonconforming Material/Component
• Action: Navilyst Medical, Inc. is recalling Vaxcel Ports and Vaxcel Ports with PASV Valve with valid expiration dates worldwide. Navilyst sent "Urgent Medical Device Recall - Immediate Action Required" letter/recall notification packages on May 13, 2010, via Federal Express to 471 domestic consignees; on May 14, 2010, via e-mail to 14 international consignees and to Boston Scientific Corporation (prior owner of the affected products) via facsimile and Federal Express. On June 3, 2010, Navilyst Medical sent Recall Notification Packages on behalf of Boston Scientific Corp. via Federal Express to 182 domestic consignees. The letter instructs the customer to immediately discontinue use of and segregate recalled product, complete and return the reply verification tracking form to fax# 518-742-4450 and package and return the recalled product to the address provided. If you have any question, please call Navilyst Medical, Inc., Customer Service at 1-800-833-9973 or Michael Duerr at 1-518-742-4571.
• Distribution: Worldwide distribution:USA and countries of Belgium, Brazil, Canada, Colombia, Croatia, Germany, Greece, Hong Kong, Italy, Saudi Arabia, South Korea, Spain, Tunisia, and United Kingdom.
• 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 = LJT