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U.S. Department of Health and Human Services

Class 2 Device Recall Tao Brush I.U.M.C. Endometrial Sampler (Tao Brush)

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 Class 2 Device Recall Tao Brush I.U.M.C. Endometrial Sampler (Tao Brush)see related information
Date Initiated by FirmApril 02, 2009
Date PostedJune 16, 2009
Recall Status1 Terminated 3 on December 03, 2009
Recall NumberZ-1416-2009
Recall Event ID 52008
510(K)NumberK082066 K941298 
Product Classification Endometrial Brush - Product Code HFE
ProductCook 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
ActionThe 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 Commerce15,396
DistributionNationwide Distribution.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HFE
510(K)s with Product Code = HFE
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