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Spectrum Medical Srl FDA Recalls
2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog NumbClass IIJul 17, 2026Due to blood-to-glycol leak in the heat exchanger. |
| Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog NumberClass IIJul 17, 2026Due to blood-to-glycol leak in the heat exchanger. |