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Recall Observatory FDA recall evidence

Device product

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

Z-2040-2014

August 17, 2011

Class II

Product summary

Firm
Codan Us Corporation
Event
Event 68591
Status
Terminated
Classification
Class II
Quantity
7250 units
Official record key
device-enforcement:Z-2040-2014

Official wording

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

Code information: Lot No. 71701, 90391, 71716, 90386, 72155, 71704, 90392, 72473, 72398, 72561, 72934, 90387, 72156, 71707, 90393, 72564, 90388, 72157, 71710, 90394, 71719, 90389, 72159, 71713, 90395, 71720, 90390, 72158.

Distribution pattern: Worldwide Distribution - US including TX, CT, NY and Internationally to Belgium.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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