ColorSafe IV lines Catalog No — Class II medical device recall Z-2040-2014
Terminated recall by Codan Us Corporation, reported 2014-07-16, distributed in CT, NY, TX. CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured
| Recall number | Z-2040-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Codan Us Corporation, Santa Ana, CA, United States |
| Recall initiated | 2011-08-17 |
| Classified | 2014-07-10 |
| Reported by FDA | 2014-07-16 |
| Terminated | 2014-07-10 |
| Distributed | CT, NY, TX |
| Countries outside the US | BE |
| Quantity | 7,250 units |
| Lot numbers | 71701, 71704, 71707, 71710, 71713, 71716, 71719, 71720, 72155, 72156, 72157, 72158, 72159, 72398, 72473, 72561, 72564, 72934, 90386, 90387, 90388, 90389, 90390, 90391, 90392, 90393, 90394, 90395 |
| Model numbers | B314, CS3000-B, CS3000-G, CS3000-O, CS3000-P, CS3000-R, CS400-B, CS400-G, CS400-O, CS400-P, CS400-R, CS408N-B, CS408N-G, CS408N-O, CS408N-P, CS408N-R |
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
Reason for recall
CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2040-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.