Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm, sterile, Cook O
FDA device recall Z-1416-2009 · posted 2009-06-16 · Terminated
Recall details
- Recalling firm
- Cook OB/Gyn, Inc.
- Reason for recall
- There is an ink on the brush which has not been tested for use with the Tao Brush.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HFE
- Quantity affected
- 15,396
- Distribution
- Nationwide Distribution.
- Date initiated
- 2009-04-02
- Date posted
- 2009-06-16
- Date terminated
- 2009-12-03
- Location
- Spencer, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TAO BRUSH I.U.M.C. ENDOMETRIAL SAMPLER (K082066) | Cook Urological, Inc. | 2008-11-07 |
| IUMC ENDOMETRIAL SAMPLER (K941298) | Cook Ob/Gyn | 1995-02-13 |