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U.S. Department of Health and Human Services

Class 2 Device Recall Vaxcel PICC with PASV Valve Technology

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  Class 2 Device Recall Vaxcel PICC with PASV Valve Technology see related information
Date Initiated by Firm November 22, 2004
Date Posted January 20, 2005
Recall Status1 Terminated 3 on December 16, 2005
Recall Number Z-0406-05
Recall Event ID 30572
510(K)Number K021704  
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
Product VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in kits, Catalog #45-454, UPN #M001454540; Firm on label: Boston Scientific, One Boston Scientific Place, Natick, MA . Manufactured at 10 Glens Falls Technical Park, Glens Falls, NY . DEVICE DESCRIPTION: A radiopaque, polyurethane catheter with a hub/suture wing, polyurethane extension leg(s) and luer locking adapter(s). A peel away sheath introducer allows for percutaneous insertion of the catheter. The hub/suture wing promotes fixation of the catheter hub to the patient''s skin. Each KIT contains: catheter; cap; tape measure, 60 cm length; stylet; stylet guide/flush assembly; attachable suture wing; statlock catheter securement device; instructions for use; 21 gauge, 2.75 inch introducer needle with echogenic tip; 60 cm guidewire with floppy tip platinum tip; 10cm peelable introducer sheath with locking dilator; 10 mL syringe, scalpel; exact length measurement chart.
Code Information 913405; 924522; 930838; 939045; 950541; 977138; 982727; 3010303254; 3010403103; 3010403104; 3011002260; 3011002261; 3011102036; 3011102037;
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
Catheter separation immediately distal to the nose of the suture wing.
FDA Determined
Cause 2
Other
Action Letters dated 11/22/2004 issued via Certified Mail. Customers instructed to return units in inventory. Patients with implanted units are to be evaluated.
Quantity in Commerce 961 kits
Distribution 75 hospitals and medical centers throughout the U.S. One foreign consignee, a hospital in New Brunswick, Canada.
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 and Original Applicant = CATHETER INNOVATIONS, INC.
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