Medical device recalls Moderate risk

DIASOL DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS recalled over labeling errors

Recall date
April 30, 2020
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Official notice title
Diasol, Inc recalls DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS
Recall number
Z-2402-2020
FDA classification
Class II
Brand / firm
Diasol, Inc
Sold / distributed
U.S.: CA O.U.S.:None

Why it was recalled

Incorrect labeling of dialysate concentration for hemodialysis.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

DIASOL 1000225-10-DEX100 LIQUID ACID CONCENTRATE FOR BICARBONATE DIALYSIS

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