Class 2 Device Recall Cook Medical Kwart RetroInject Ureteral Stent

• Date Initiated by Firm: January 04, 2021
• Create Date: February 05, 2021
• Recall Status: Terminated on September 16, 2021
• Recall Number: Z-0960-2021
• Recall Event ID: 87087
• 510(K)Number: K162109
• Product Classification: Stent, ureteral - Product Code FAD
• 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
• Code Information: Lot Numbers: 13024536 13089895 NS13089897 UDI: (01)00827002148376(17)230303(10)13024536 (01)00827002148376(17)230327(10)13089895 (01)00827002148376(17)230327(10)NS13089897
• Recalling Firm/ Manufacturer: Cook Inc.; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customer Relations Department; 800-457-4500
• Manufacturer 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.
• FDA Determined 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(FieldActionsNA@CookMedical.com). 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: CustomerRelationsNA@CookMedical.com.
• Quantity in Commerce: 42 units
• Distribution: FL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = FAD and Original Applicant = COOK INCORPORATED