Date Initiated by Firm |
November 17, 2006 |
Date Posted |
December 07, 2006 |
Recall Status1 |
Terminated 3 on January 12, 2007 |
Recall Number |
Z-0260-2007 |
Recall Event ID |
36850 |
510(K)Number |
K923878
|
Product Classification |
Tracheostomy Tube - Product Code JOH
|
Product |
Custom 5.5 mm Bivona¿ Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S. |
Code Information |
Lot CL47189. |
Recalling Firm/ Manufacturer |
Smiths Medical ASD, Inc. 5700 W 23rd Ave Gary IN 46406-2617
|
For Additional Information Contact |
800-858-7670 Ext. 5542
|
Manufacturer Reason for Recall |
Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.
|
FDA Determined Cause 2 |
Other |
Action |
The consignee was notified of the problem via recall letter sent on 11/17/06 and given the options of continuing to use the product or of returning it. |
Quantity in Commerce |
5 |
Distribution |
New York-single hospital consignee |
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
|