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.
Reported: January 17, 2018 Initiated: November 15, 2017 #Z-0324-2018
Product Description
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
Details
- Recalling Firm
- Cordis Corporation
- Units Affected
- 511
- 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.
- Location
- Miami Lakes, FL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cordis Corporation. Units affected: 511.
Why was this product recalled? ▼
Potential for cracked luer hubs
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 17, 2018. Severity: Moderate. Recall number: Z-0324-2018.
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