Z-0971-2020Class II

Urethral Dilator Set, Global Product No. G14185

Name: Z-0971-2020 Urethral Dilator Set, Global Product No. G14185
Creator: Cook Inc.
Published: 2019-01-04
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2019-01-04 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of Urethral Dilator Set, Global Product No. G14185 on 2019-01-04. FDA classified it as Class II and gives the reason as "The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip". 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-0971-2020
Classification: Class II
Status: Terminated
Initiated: 2019-01-04
Posted: 2020-02-04
Terminated: 2020-05-29
Recalling firm: Cook Incorporated
Product: Urethral Dilator Set, Global Product No. G14185
Product code: KOE Dilator, Urethral
Reason for recall: The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: On January 4, 2019, the firm distributed Urgent Medical Device Recall letters to customers via courier mail. Customers were informed that affected lots may contain a wire guide that was incorrectly loaded into the wire guide holder.
Quantity in commerce: 13388 total
Distribution: Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, and the United Kingdom.
Product codes and lots: 8401849 8404945 8404946 8417702 8404946X

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0971-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0959-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0960-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0961-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0962-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0963-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0964-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0965-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0966-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0967-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0968-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0969-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0970-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0971-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0972-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0973-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0974-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0975-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0976-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0977-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04
Z-0978-2020	Class II	Terminated	Voluntary: Firm initiated	2020-02-12	2020-02-04

Product code KOE

K811833Class IIVnace Fascial Dilator SetVance Products, Inc. / cleared 1981-07-10

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)