Z-0960-2021Class II

Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during...

Name: Z-0960-2021 Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during...
Creator: Cook Inc.
Published: 2021-01-04
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2021-01-04 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and... on 2021-01-04. FDA classified it as Class II and gives the reason as "Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation". 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-0960-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-04
Posted: 2021-02-05
Terminated: 2021-09-16
Recalling firm: Cook Incorporated
Product: Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837
Product code: FAD Stent, Ureteral
Reason for recall: Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: Cook issued Urgent Medical Device Recall Letter on Jan 4 , 2021 via email/mail. Letter states reason for recall, health risk and action to take: If affected products are currently indwelling in a patient, consider scheduling a follow-up with the patient to remove and/or replace the product, based on the status and preferences of each individual patient. 2.Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all distribution and use of this product. 3.Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. Note: Unaffected products that are returned will not be credited. 4.Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email([email protected]). 5.This notice must be shared with appropriate personnel, including down to the user level, with in your organization or with any organization where the potentially affected devices have been transferred. 6.Immediately report adverse events to Cook Medical Customer Relations by phone at800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (EasternTime), or by email to: [email protected].
Quantity in commerce: 42 units
Distribution: FL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland
Product codes and lots: Lot Numbers: 13024536 13089895 NS13089897 UDI: (01)00827002148376(17)230303(10)13024536 (01)00827002148376(17)230327(10)13089895 (01)00827002148376(17)230327(10)NS13089897

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0960-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0960-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-05

Product code FAD

K162109Class IIKwart Retro-Inject Ureteral StentCook Incorporated / cleared 2017-06-07

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)