Date Initiated by Firm |
February 25, 2005 |
Date Posted |
April 28, 2005 |
Recall Status1 |
Terminated 3 on August 09, 2006 |
Recall Number |
Z-0781-05 |
Recall Event ID |
31251 |
510(K)Number |
K031844
|
Product Classification |
Port & Catheter, Implanted, Subcutaneous, Intraperitoneal - Product Code LLD
|
Product |
Vaxcel Low Profile Port with PASV valve and 8F Silicone Catheter. CATALOG NO. 45-236, Ref. # M001452360. FIRM ON LABEL: Boston Scientific MEDI-TECH. Manufactured for: Boston Scientific Corp., One Boston Scientific Place, Natick, MA 01760-1537. Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801. |
Code Information |
Cat. No. 45-236, including all lots as follows: 791486, 906776, 916194, 917025 |
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 |
Potential separation of the port base from the port cover after implantation.
|
FDA Determined Cause 2 |
Other |
Action |
Letters sent 3/11/2005 via Federal Express to hospitals receiving affected product. Customers instructed to remove/return product, notify physicians, evaluate patients and explant devices whenever possible. |
Quantity in Commerce |
214 units |
Distribution |
1215 units shipped to 123 hospitals throughout the U.S. 2 units shipped to Boston Scientific in South Africa where 1 unit had been used as a demo (non-human use) and 1 units is in BSC control |
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.
|
510(K) Database |
510(K)s with Product Code = LLD and Original Applicant = BOSTON SCIENTIFIC CORP.
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