Z-1416-2009

Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm...

Name: Z-1416-2009 Cook Medical Tao Brush I.U.M.C. Endometrial Cytology/Histology Sampler (Tao Brush), 9.0Fr/26 cm, 3.5 cm...
Creator: Cook OB/Gyn, Inc.
Published: 2009-04-02
License: https://open.fda.gov/license/

Cook Ob/Gyn / initiated 2009-04-02 / Terminated / root cause: manufacturing process

FDA source

Cook OB/Gyn, Inc. began a recall of 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... on 2009-04-02. The reason FDA records is "There is an ink on the brush which has not been tested for use with the Tao Brush". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1416-2009
Status: Terminated
Initiated: 2009-04-02
Posted: 2009-06-16
Terminated: 2009-12-03
Recalling firm: Cook Ob/Gyn
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.
Product code: HFE Brush, Endometrial
Reason for recall: There is an ink on the brush which has not been tested for use with the Tao Brush.
Root cause tag: manufacturing process
FDA 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 in commerce: 15,396
Distribution: Nationwide Distribution.
Product codes and lots: Lots UF1793872 through UF1793877, UF1811910 through UF1811913, UF1811916, UF1811917, UF1811917S, UF1811918, UF1811919, UF1816687 and UF1816688.

Product code HFE

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)