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ICU Medical
ICU MEDICAL, INC. · Model 011-CGHD-100 · UDI-DI 00887709123595
PEH
Prescription
1
510(k) clearances
9
Adverse events
1
Recalls
6
Facilities
Description
ClearGuard® HD
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-02-15 | Transonic Systems Inc | The sterility of the device cannot be assured. There is a potential for an increased risk of infection. |
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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.