|
Class 2 Device Recall Tao Brush I.U.M.C. Endometrial Sampler (Tao Brush) |
|
Date Initiated by Firm |
April 02, 2009 |
Date Posted |
June 16, 2009 |
Recall Status1 |
Terminated 3 on December 03, 2009 |
Recall Number |
Z-1416-2009 |
Recall Event ID |
52008 |
510(K)Number |
K941298 K082066
|
Product Classification |
Endometrial Brush - Product Code HFE
|
Product |
Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook Ob/Gyn, Spencer, IN; REF J-ES-090500-BL.
Used to obtain endometrial samples for both cytology and histology. Intended for one-time use. |
Code Information |
Lots UF1793872 through UF1793877, UF1811910 through UF1811913, UF1811916, UF1811917, UF1811917S, UF1811918, UF1811919, UF1816687 and UF1816688. |
Recalling Firm/ Manufacturer |
Cook OB/Gyn, Inc. 1100 West Morgan St. Spencer IN
|
For Additional Information Contact |
812-339-2235
|
Manufacturer Reason for Recall |
There is an ink on the brush which has not been tested for use with the Tao Brush.
|
FDA Determined Cause 2 |
Process control |
Action |
The consignee was notified by an Urgent: Recall Notice letter dated 4/2/09. The customer is to forward the notice to all personnel that need to be aware of it; pull from their stock and isolate any affected product; and complete the form. Upon receipt of the form, Cook Women's Health will issue a Return Goods Authorization number and the customer should return the affected products via FedEx using the Return Goods Authorization number. |
Quantity in Commerce |
15,396 |
Distribution |
Nationwide Distribution. |
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 = HFE and Original Applicant = COOK OB/GYN 510(K)s with Product Code = HFE and Original Applicant = COOK UROLOGICAL, INC.
|
|
|
|