| Class 2 Device Recall Vaxcel PICC with PASV Valve Technology | |
Date Initiated by Firm | November 22, 2004 |
Date Posted | January 20, 2005 |
Recall Status1 |
Terminated 3 on December 16, 2005 |
Recall Number | Z-0404-05 |
Recall Event ID |
30572 |
510(K)Number | K021704 |
Product Classification |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
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Product | VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catalog #45-451, UPN #M001454510, 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; Peelaway Sheath Introducer; 10 mL Syringe; CSR Wrap. |
Code Information |
933284 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Boston Scientific Pl Natick MA 01760-1536
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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 | 167 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 |
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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.
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510(K) Database | 510(K)s with Product Code = LJS
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