| Date Initiated by Firm |
July 22, 2005 |
| Date Posted |
September 02, 2005 |
| Recall Status1 |
Terminated 3 on June 20, 2007 |
| Recall Number |
Z-1479-05 |
| Recall Event ID |
32694 |
| 510(K)Number |
K903364
|
| Product Classification |
Catheter, Suprapubic (And Accessories) - Product Code KOB
|
| Product |
Vaxcel¿ Chest Ports - Standard/T/S/8/1.5/2.6/63
Catalog Number : 45-320
|
| Code Information |
Lot Numbers: 898470 914482 917575 934741 937479 941713 977486 979330 992196 1000903 1001278 941713D |
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 = GERARD MEDICAL ENTERPRISES, INC.
|
