Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr.… recallZ-0960-2021 · Cook Inc. · initiated Jan 4, 2021

Why it was recalled

Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.

FDA root cause category: Nonconforming Material/Component

What the company is doing

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].

Recall details

Recall number

Z-0960-2021

Status

Terminated

Initiated by the company

Jan 4, 2021

Recalling firm

Cook Inc.

Quantity

42 units

Product code

FAD

FDA submissions

K162109

Distribution

FL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland

Product description

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

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

• Kwart G14837

  Cook Incorporated · STENT, URETERAL
  1 recall0 reports