Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0324-2018 — 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.

U.S. FDA — Device Enforcement · United States · 2017-11-15 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0324-2018
Date of alert: 2017-11-15
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Cordis Corporation
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 20705032065600

Reported risk: Potential for cracked luer hubs

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0324-2018 — 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.

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