| Class 2 Device Recall ColorSafe IV Administration sets and components | |
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 |
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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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