Z-0963-2020Class II

Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866

Name: Z-0963-2020 Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
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 Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866 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-0963-2020
Classification: Class II
Status: Terminated
Initiated: 2019-01-04
Posted: 2020-02-04
Terminated: 2020-05-29
Recalling firm: Cook Incorporated
Product: Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
Product code: OCY Endoscopic Guidewire, Gastroenterology-Urology
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: 7853231 7853232 7853233 7853239 7853240 7853241 7853242 7853243 7853245 7853247 7901140 7901141 7982113 7982118 7982133 8050291 8241613 8241616 8252179 8252181 8252186 8258553 8283322 8407934 8460985 8474895 8474898 8474905 8474906 8474908 8474909 8474910 7936207

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0963-2020
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 OCY

K082536Class IICook Wire GuidesCook Urological, Inc. / cleared 2008-10-27

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)