Recall Z-1416-2009 ยท HFE Brush, Endometrial
Cook OB/Gyn, Inc.
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.
| Date | Jun 16, 2009 (initiated Apr 2, 2009) |
| Status | Terminated |
| Reason | There is an ink on the brush which has not been tested for use with the Tao Brush. |
| Root cause | 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 | 15,396 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |