PlainRecalls
FDA Devices Moderate Class II Terminated

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-G (76.8004), CS3000-P (76.7810), CS400-P (76.7804), CS408N-P (76.8003). Intravenous administration sets

Reported: July 16, 2014 Initiated: August 17, 2011 #Z-2040-2014

Product Description

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-G (76.8004), CS3000-P (76.7810), CS400-P (76.7804), CS408N-P (76.8003). Intravenous administration sets

Reason for Recall

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

Details

Recalling Firm
Codan Us Corporation
Units Affected
7250 units
Distribution
Worldwide Distribution - US including TX, CT, NY and Internationally to Belgium.
Location
Santa Ana, CA

Frequently Asked Questions

What product was recalled? ▼
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-G (76.8004), CS3000-P (76.7810), CS400-P (76.7804), CS408N-P (76.8003). Intravenous administration sets. Recalled by Codan Us Corporation. Units affected: 7250 units.
Why was this product recalled? ▼
CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 16, 2014. Severity: Moderate. Recall number: Z-2040-2014.

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