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

Recall Z-2040-2014 — ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R (76.7800), CS408N-R (76.8000), CS3000-B (76.7807), B314 (25.7406), CS400-B (76.7801), CS408N-B (76.8001), CS3000-O (76.7808), CS400-O (76.7802), CS408N-O (76.8002), CS3000-G (76.7809), CS400-G (76.7803), CS408N-

U.S. FDA — Device Enforcement · United States · 2011-08-17 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-2040-2014
Date of alert: 2011-08-17
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: Codan Us Corporation
Product category: device
Product type: Devices

Reported risk: CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval.

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.

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