Z-0975-2020Class II

Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128

Name: Z-0975-2020 Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
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 Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128 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-0975-2020
Classification: Class II
Status: Terminated
Initiated: 2019-01-04
Posted: 2020-02-04
Terminated: 2020-05-29
Recalling firm: Cook Incorporated
Product: Sof-Flex Double Pigtail Ureteral Stent Set, Global Product No. G15076 G14906 G14840 G14865 G17128
Product code: FAD Stent, Ureteral
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: NS7949093 NS8077953 NS8077954 NS8077955 8070691 8183342 8183343 8070693 8172134 8187189 NS8070692 8424304 7990841

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0975-2020
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 FAD

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)