FDA Device Intelligence
HomeICU MEDICAL, INC. › Portex

Portex

ICU MEDICAL, INC. · Model 100/465/060CZ · UDI-DI 35019315110522

BWC Prescription
10
510(k) clearances
22
Adverse events (2 deaths)
2
Recalls
15
Facilities

Recalls

DateFirmReason
2026-03-05Cook IncorporatedProducts from the affected device lots were labeled with expiration dates that exceed the true shelf life.
2019-11-15Tytek Medical IncA defect involving an occluded needle was discovered during a training exercise.

Query this across every FDA database — by API.

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

Get your free API keyRead the docs
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.