# FDA recall Z-0960-2021

> **Cook Inc.** · Class II · device recall initiated 2021-01-04.

## Product

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

## Reason for recall

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

## Distribution

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

## Key facts

- **Recall number:** Z-0960-2021
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-01-04
- **Report date:** 2021-02-17
- **Termination date:** 2021-09-16

- **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-0960-2021

## Citation

> AI Analytics. FDA recall Z-0960-2021. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-0960-2021. Source: US FDA. Licensed CC0.

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