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Portex

ICU MEDICAL, INC. · Model 100/179/090 · UDI-DI 15019315022166

NTR Prescription
1
510(k) clearances
2
Adverse events
1
Recalls
1
Facilities

Recalls

DateFirmReason
2015-10-27Lab Vision CorporationIt was discovered that the labeling of MS-230 antibody incorrectly describes the concentration - label reads 0.2mg/ml but it is actually 0.4 mg/ml.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.