Z-2040-2014 Class II Terminated
FDA device recall Z-2040-2014 was initiated by Codan Us Corporation on August 17, 2011 and is designated Class II. Reason for recall: CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval. The recall status is terminated (terminated July 10, 2014). Affected quantity: 7250 units.
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.