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Additive
ICU Medical, Inc. · Model 485801 · UDI-DI 10887787001874
KPE
Prescription
10
510(k) clearances
6,805
Adverse events (8 deaths)
62
Recalls
86
Facilities
Description
LATEX-FREE ADDITIVE HINGE CAP LifeCare Flexible Container
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
| 2024-10-09 | The Metrix Company | A limited number of IV bags have been found to leak during filling. |
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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.