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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
| Date | Firm | Reason |
|---|---|---|
| 2026-03-05 | Cook Incorporated | Products from the affected device lots were labeled with expiration dates that exceed the true shelf life. |
| 2019-11-15 | Tytek Medical Inc | A defect involving an occluded needle was discovered during a training exercise. |
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Get your free API keyRead the docsData 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.
