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U.S. Department of Health and Human Services

Class 2 Device Recall ColorSafe IV Administration sets and components

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  Class 2 Device Recall ColorSafe IV Administration sets and components see related information
Date Initiated by Firm August 17, 2011
Date Posted July 10, 2014
Recall Status1 Terminated 3 on July 10, 2014
Recall Number Z-2040-2014
Recall Event ID 68591
Product Classification Set, administration, intravascular - Product Code FPA
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
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.
Recalling Firm/
Manufacturer		 Codan Us Corporation
3511 W Sunflower Ave
Santa Ana CA 92704-6944
For Additional Information Contact
714-545-2111
Manufacturer Reason
for Recall		 CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval.
FDA Determined
Cause 2		 Other
Action 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.
Quantity in Commerce 7250 units
Distribution Worldwide Distribution - US including TX, CT, NY and Internationally to Belgium.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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