# FDA recall Z-1369-2019

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

## Product

Cook Kwart Retro-Inject Ureteral Stent Set:  PRODUCT/CATALOG NUMBER/GPN:   4.7 Fr   003500  G14916;  6.0 Fr   003600  G14836;  7.0 Fr   003700  G14837;  8.0 Fr   003800  G14844;    Set with AQ¿ Hydrophilic Coating  PRODUCT/CATALOG NUMBER/GPN:  4.7 Fr    AQ-003500  G17150;  6.0 Fr    AQ-003600 G17151;  7.0 Fr    AQ-003700 G17152

## 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-1369-2019
- **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-1369-2019

## Citation

> AI Analytics. FDA recall Z-1369-2019. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/Z-1369-2019. Source: US FDA. Licensed CC0.

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