RegWardenFDA facility compliance records
Facility

CODAN US CORP.

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2011: 1 recalls; 2018: 1 inspections; 2019: 1 recalls1’11’12’13’14’15’16’171’181’19’20’21’22’23’24’25’26
  • Recalls (2)
  • Inspections (1)

Devices registered here (1)

Recalls & enforcement

  • Class IITerminated2019-09-12
    Individual packages of connectors may have incomplete or bad seals which would compromise sterility.
  • Class IITerminated2011-08-17
    CODAN US Corporation is recalling the ColorSafe IV (intravenous) product lines because they were manufactured and marketed prior to FDA approval.

FDA inspections (1)

  • VAI2018-07-20
    Voluntary Action Indicated · Compliance: Devices; Postmarket Assurance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “CODAN US CORP. (FEI 2016945) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2016945-codan-us-corp/

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