Z-2971-2020Class II

Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 -

Name: Z-2971-2020 Cook Medical Universa Soft Ureteral Stent Sets-5 FR 26 cm Reference part Number: UFH-526 -
Creator: Cook Inc.
Published: 2020-07-30
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2020-07-30 / Terminated / root cause: labeling and UDI

FDA source

Cook Inc. began a recall of 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... on 2020-07-30. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2971-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-30
Posted: 2020-09-15
Terminated: 2021-11-04
Recalling firm: Cook Incorporated
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
Product code: FAD Stent, Ureteral
Reason for recall: 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 tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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 ([email protected]). 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:[email protected].
Quantity in commerce: 20 units
Distribution: International distribution to the country of Australia.
Product codes and lots: Lot Number: 13060084

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2971-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2971-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-23	2020-09-15

Product code FAD

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)