Recall Z-2971-2020 ยท FAD Stent, Ureteral
Cook Inc.
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
| Date | Jul 30, 2020 |
| Status | Terminated |
| Reason | 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 | 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 Acknowle |
| Quantity | 20 units |
| Distribution | International distribution to the country of Australia. |
| FDA record | Open on fda.gov |