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
Recall
- Recall Number
- Z-2040-2014
- Event Number
- 68591
- Firm
- Codan Us Corporation
- FEI Number
- 2016945
- Product Code
- FPA
- Status
- Terminated
- Root Cause
- Other
- Initiated
- August 17, 2011
- Posted
- July 10, 2014
- Terminated
- July 10, 2014
- Address
- 3511 W Sunflower Ave, Santa Ana, CA, 92704-6944
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
CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval.
CODAN sent a recall letter dated August 17, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to return any of the affected product. If they sold the product they should provide Codan the name and address of the customer. so that they may be contacted to retrieve the shipped products. Customers were instructed to contact CODAN Customers Service for a Returned Goods Authorization. Customers with questions were instructed to call 714-430-1303. Customers were instructed to not send used devices.For questions regarding this recall call 714-545-2111.
Worldwide Distribution - US including TX, CT, NY and Internationally to Belgium.
7250 units