Home / Recalls / Codan Us Corporation / Z-2040-2014

Z-2040-2014 Class II Terminated

Recalled by Codan Us Corporation — Santa Ana, CA

Recall Details

Product Type: Devices
Report Date: July 16, 2014
Initiation Date: August 17, 2011
Termination Date: July 10, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 7250 units

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.

Distribution Pattern

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

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.