Date Initiated by Firm |
April 26, 2005 |
Date Posted |
June 25, 2005 |
Recall Status1 |
Terminated 3 on October 26, 2005 |
Recall Number |
Z-0930-05 |
Recall Event ID |
31856 |
510(K)Number |
K914088
|
Product Classification |
Tube Tracheostomy And Tube Cuff - Product Code JOH
|
Product |
Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
|
Code Information |
Lot G651610. |
Recalling Firm/ Manufacturer |
Smiths Medical ASD, Inc. 5700 W 23rd Ave Gary IN 46406-2617
|
For Additional Information Contact |
800-424-8662
|
Manufacturer Reason for Recall |
The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.
|
FDA Determined Cause 2 |
Other |
Action |
Consignees were notified via letter dated 4/26/05. |
Quantity in Commerce |
48 |
Distribution |
Connecticut, Georgia, Illinois, Indiana, Minnesota, Missouri, New Mexico, and North Carolina. |
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 = JOH and Original Applicant = BIVONA MEDICAL TECHNOLOGIES
|