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EXACTAMIX

HAEMOTRONIC SPA · Model E3030OD · UDI-DI 08033718000989

KPE Prescription
10
510(k) clearances
6,755
Adverse events (8 deaths)
62
Recalls
85
Facilities

Description

3000 mL Exactamix Empty EVA bag

Recalls

DateFirmReason
2024-10-09The Metrix CompanyA limited number of IV bags have been found to leak during filling.
2024-10-09The Metrix CompanyA limited number of IV bags have been found to leak during filling.
2024-10-09The Metrix CompanyA limited number of IV bags have been found to leak during filling.
2024-10-09The Metrix CompanyA limited number of IV bags have been found to leak during filling.
2024-10-09The Metrix CompanyA limited number of IV bags have been found to leak during filling.
2024-10-09The Metrix CompanyA limited number of IV bags have been found to leak during filling.
2024-10-09The Metrix CompanyA limited number of IV bags have been found to leak during filling.
2024-10-09The Metrix CompanyA limited number of IV bags have been found to leak during filling.
2024-10-09The Metrix CompanyA limited number of IV bags have been found to leak during filling.
2024-10-09The Metrix CompanyA limited number of IV bags have been found to leak during filling.

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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.