# FDA recall Z-2971-2020

> **Cook Inc.** · Class II · device recall initiated 2020-07-30.

## 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

## 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.

## Distribution

International distribution to the country of Australia.

## Key facts

- **Recall number:** Z-2971-2020
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-30
- **Report date:** 2020-09-23
- **Termination date:** 2021-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bloomington, IN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2971-2020

## Citation

> AI Analytics. FDA recall Z-2971-2020. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-2971-2020. Source: US FDA. Licensed CC0.

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