ColorSafe IV lines Catalog No.(Model No.) CS3000-R (76.7806), CS400-R (76.7800), CS408N-R (76.8000), CS3000-B (76.7807),

FDA device recall Z-2040-2014 · posted 2014-07-10 · Terminated

Recall details

Recalling firm

Codan Us Corporation

Reason for recall

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

Action taken

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.

Root cause

Other

Status

Terminated

Product code

FPA

Quantity affected

7250 units

Distribution

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

Date initiated

2011-08-17

Date posted

2014-07-10

Date terminated

2014-07-10

Location

Santa Ana, CA