# FDA recall Z-1370-2019

> **Cook Inc.** · Class II · device recall initiated 2019-04-22.

## Product

Cook Salle Intraoperative Pyeloplasty Stent Set  PRODUCT/CATALOG NUMBER/GPN:   4.0 Fr  - SIPSF-040018-56-6    G18168  4.0 Fr  - SIPSF-040018-59       G32773  4.7 Fr   SIPSF-050018-59       G32774

## Reason for recall

Kwart RetroInject Stent Set (Multi-Length) and Salle Intraoperative Pyeloplasty Stent Set  Instructions for Use (IFU) did not include a warning for stent knotting.

## Distribution

Nationwide  Foreign:  Australia  Canada  Austria  Belgium  Denmark  Germany  Spain  Finland  France  Martinique  French Polynesia  Switzerland  Ireland  Italy  Netherlands  Poland  Sweden  United Kingdom  Hong Kong  New Zealand  Chile  Colombia  Israel  Russian Federation  Czech Republic  Greece  Jordan  Slovakia  South Africa  United Arab Emirates  Slovenia  Lithuania  Morocco  Romania  Qatar  Bulgaria  Libya  Saudi Arabia  Turkey  Ukraine  Thailand

## Key facts

- **Recall number:** Z-1370-2019
- **Recalling firm:** Cook Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-22
- **Report date:** 2019-05-29
- **Termination date:** 2020-05-05

- **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-1370-2019

## Citation

> AI Analytics. FDA recall Z-1370-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/Z-1370-2019. Source: US FDA. Licensed CC0.

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