—#183230

Product

Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 - Product Usage: Used for temporary internal drainage from the ureteropelvic junction to the bladder

FDA product code: FAD — Stent, Ureteral
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K151051, K161236
Affected lot / code info: Lot Number: 13060084

Why it was recalled

Universa Soft Ureteral Stent Sets were incorrectly placed in the outer boxes labeled as Universa Firm Ureteral Stent Set ;pouch label reflects the packaged product.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Cook Medical notified William Cook Australia (WCA) on July 30, 2020. WCA notified customers on August 11, 2020. Letter states reason for recall, health risk and action to take: Actions to be Taken by the Customer 1. If affected products have already been placed within a patient, the indwell time should not exceed 180 days. 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, within 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 at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to:CustomerRelationsNA@CookMedical.com.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

Distribution pattern: International distribution to the country of Australia.

Timeline

Recall initiated: 2020-07-30
Terminated: 2021-11-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #183230. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.