Recall Z-1416-2009
Cook OB/Gyn, Inc. · initiated April 2, 2009
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.
Codes / lots: Lots UF1793872 through UF1793877, UF1811910 through UF1811913, UF1811916, UF1811917, UF1811917S, UF1811918, UF1811919, UF1816687 and UF1816688.
Reason for recall
There is an ink on the brush which has not been tested for use with the Tao Brush.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-1416-2009
- Initiated
- April 2, 2009
- Posted by FDA
- June 16, 2009
- Terminated
- December 3, 2009
- Product code
- HFE – Brush, Endometrial
- Quantity
- 15,396
- Distribution
- Nationwide Distribution.
- Recalling firm
- Cook OB/Gyn, Inc., Spencer, IN