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U.S. Department of Health and Human Services

Class 1 Device Recall Vaxcel

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 Class 1 Recall
Vaxcel
see related information
Date Posted July 01, 2010
Recall Status1 Terminated on August 03, 2012
Recall Number Z-1883-2010
Recall Event ID 55786
Premarket Notification
510(K) Numbers
K903364  K942623  K945250  K954258 
Product Classification Port & Catheter, Implanted, Subcutaneous, Intravascular - Product Code LJT
Product Navilyst Medical, Inc., Vaxcel(TM) Port Titanium Mini-Port with 8F Silicone Catheter (1.5 mm/2.6 mm), REF Catalog No. 45-310, UPN Product No. M001453100, STERILE, Rx ONLY, For single use only --- Implantable Vascular Access System --- (kit contains Huber needle) -- previously distributed by Boston Scientific Corporation.
Code Information Lots 1263714, 1264775, 1267694, 1269714, 1272320, 1273699, 1275502, 1276598, 1283244, 1284100, 1285146, 1285400, 1286080, 1287098, 1288650, 1292669, 1294481, 1295072, 1297671, 1299594, 1301292, 1310032, 1312322, 1316808, 1321707, 1345647, 1346950, 1354323, 1355340, 1359541, 1360401, 1364170, 1367275, 1373685, 1381270, 4001734
Recalling Firm/
Manufacturer
Navilyst Medical, Inc
10 Glens Falls Technical Park
Glens Falls, New York 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 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LJT and Original Applicant = GERARD MEDICAL ENTERPRISES, INC.
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