Date Initiated by Firm |
July 22, 2005 |
Date Posted |
September 02, 2005 |
Recall Status1 |
Terminated 3 on June 20, 2007 |
Recall Number |
Z-1472-05 |
Recall Event ID |
32694 |
510(K)Number |
K032008
|
Product Classification |
Catheter, Suprapubic (And Accessories) - Product Code KOB
|
Product |
Vaxcel¿ Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Mini/T/PU/6/1.1/1.9/63 Catalog Number : 45-213
|
Code Information |
Lot Numbers: 929652 958506 959672 960718 970274 979014 979328 986234 1001729 1028094 1030285 |
Recalling Firm/ Manufacturer |
Boston Scientific Corporation 1 Boston Scientific Pl Natick MA 01760-1536
|
For Additional Information Contact |
Cindy Finney 508-683-4678
|
Manufacturer Reason for Recall |
The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.
|
FDA Determined Cause 2 |
Other |
Action |
Boston Scientific intiated the recall on 7/22/05 to direct accounts and to distributors on 7/ 27 /05. Distributors are requested to conduct sub recalls to the medical facility level. A revised letter dated 8/2/05 was sent to 18 US accounts for one lot (#1020895) omitted in the letter of 7/22/05. |
Distribution |
Nationwide
VA Hopsitals
Foreign: Canada, Africa, Japan, Israel, Japan, Nertherlands, Venezula |
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 = KOB and Original Applicant = BOSTON SCIENTIFIC CORP.
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