# FDA recall Z-0324-2018

> **Cordis Corporation** · Class II · device recall initiated 2017-11-15.

## Product

Cordis S.M.A.R.T. Flex Biliary Stent System    Product Usage:  Is indicated for use in the palliation of malignant strictures in the biliary tree.

## Reason for recall

Potential for cracked luer hubs

## Distribution

Worldwide Distribution - US Nationwide in the states of MI, AL, AR, CA, CO, FL,  GA, IL, IA, LA, MS, NJ, NC, OH, OK, OR, PA, TN, TX, VA, WV, WI, MI, NY, MA, NV, RI, IN, WA, AZ, DC, Puerto Rico and the country of Canada.

## Key facts

- **Recall number:** Z-0324-2018
- **Recalling firm:** Cordis Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2017-11-15
- **Report date:** 2018-01-17
- **Termination date:** 2019-11-04

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Miami Lakes, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0324-2018

## Citation

> AI Analytics. FDA recall Z-0324-2018. Retrieved 2026-06-30 from https://api.ai-analytics.org/recall/Z-0324-2018. Source: US FDA. Licensed CC0.

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