Date Initiated by Firm | July 22, 2005 |
Date Posted | September 02, 2005 |
Recall Status1 |
Terminated 3 on June 20, 2007 |
Recall Number | Z-1482-05 |
Recall Event ID |
32694 |
510(K)Number | K030083 |
Product Classification |
Catheter, Suprapubic (And Accessories) - Product Code KOB
|
Product | Vaxcel Implantable Chest Ports With PASV Valve Technology - Vaxcel w/PASV Standard/T/PU/8/1.6/2.6/63
Catalog Number : 45-362 |
Code Information |
Lot Numbers: 904746 905284 916199 917958 919483 920317 920762 922096 922595 922596 924197 973170 979018 1001738 922596D |
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 |
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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 = KOB
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