CLASS II Device recall · Reported 16 Jul 2014 · FDA Enforcement Report
ColorSafe IV lines recalled by Codan Us
Codan Us is recalling ColorSafe IV lines, distributed nationwide in the US. The recall was initiated on 17 Aug 2011 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2040-2014
- FDA event ID
- 68591
- Recalling firm
- Codan Us, Santa Ana, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 17 Aug 2011
- FDA classified
- 10 Jul 2014
- Reported
- 16 Jul 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Infusion Pumps
Timeline
| 17 Aug 2011 | Recall initiated by company | |
| 10 Jul 2014 | Classified by FDA | +1058 days |
| 16 Jul 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval.
Product as listed by the FDA
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
Where it was distributed
Worldwide Distribution - US including TX, CT, NY and Internationally to Belgium.
Questions about this recall
Is ColorSafe IV lines recalled?
Yes. Codan Us recalled ColorSafe IV lines on 17 Aug 2011. The recall is Class II and its status is Terminated. Recall number Z-2040-2014.
Why was it recalled?
CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval.
Which lots are affected?
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.
Where was it sold?
Worldwide Distribution - US including TX, CT, NY and Internationally to Belgium.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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