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Class 2 Device Recall |
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Date Initiated by Firm |
March 29, 2004 |
Date Posted |
July 20, 2004 |
Recall Status1 |
Terminated 3 on October 13, 2005 |
Recall Number |
Z-0847-04 |
Recall Event ID |
28675 |
510(K)Number |
K991897
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Product |
Titanium Dual Lumen Implantable Port with PASV Valve and 10F Silicone Catheter. Catalog No/REF: PRTB10A, Model No. M001PRTB10A. Firm on label: Boston Scientific Corp., NAMIC Technology Center, Glens Falls, NY 12801. |
Code Information |
916252, 917973 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Boston Scientific Pl Natick MA 01760-1536
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For Additional Information Contact |
Nancy Cutino 508-652-5066
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Manufacturer Reason for Recall |
Catheters may not have adequate radiopacity for proper visualization under fluoroscopy.
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FDA Determined Cause 2 |
Other |
Action |
Letters dated 3/29/04 with instruction to remove and return product. |
Quantity in Commerce |
72 units |
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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 = and Original Applicant = CATHETER INNOVATIONS, INC.
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