Recall Z-2040-2014— Codan Us Corporation
Class II · Terminated
Class II FDA medical device recall by Codan Us Corporation, initiated 2011-08-17, terminated 2014-07-10. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval..
- Recalling firm
- Codan Us Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2011-08-17
- Terminated
- 2014-07-10
- Firm location
- Santa Ana, CA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.