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EcoFLX™ Empty Mixing Container

DOUGLAS MEDICAL PRODUCTS, INC. · Model DME5001 · UDI-DI 10816415020697

KPE Prescription
1
510(k) clearances
6,773
Adverse events (8 deaths)
62
Recalls
85
Facilities

Description

EcoFLX 5000mL Empty IV Mixing Container with 1 Spike Lead (EVA)

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.