Codan Recalls ColorSafe IV Lines Manufactured Before FDA Approval
Codan US Corporation is recalling ColorSafe IV lines because they were manufactured and marketed prior to FDA approval.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any injuries, illnesses, or specific physical hazards, fitting the criteria for a voluntary precautionary recall or minor regulatory issue.
Plain-English summary
Codan US Corporation is recalling specific models of ColorSafe IV (intravenous) lines. The affected products include various catalog numbers such as CS3000-R, CS400-R, and CS408N-R, among others, manufactured by Codan US Corporation.
The recall was initiated because these products were manufactured and marketed prior to FDA approval. The recall covers 7,250 units distributed worldwide, including in the United States (Texas, Connecticut, New York) and internationally to Belgium.
Healthcare providers and consumers should stop using these specific IV lines and contact Codan US Corporation for further instructions or a replacement.
The recalled product
- 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)…
- Manufacturer
- Codan Us Corporation
- Hazard
- Affected units
- 7,250
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot No. 71701
- 90391
- 71716
- 90386
- 72155
- 71704
- 90392
- 72473
- 72398
- 72561
- 72934
- 90387
- 72156
- 71707
- 90393
- 72564
- 90388
- 72157
- 71710
- 90394
Distribution
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