Medical device recalls Moderate risk

Baxter Healthcare Corp. recalls MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.

Recall date
January 22, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1269-2015
FDA classification
Class II
Brand / firm
Baxter Healthcare Corp.
Sold / distributed
Worldwide Distribution - Nationwide Distribution and to the countries of : Canada, Austria, Norway, Portugal, Saudi Arabia and Spain.

Why it was recalled

Product may have separating or protruding sponges

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

What was recalled

MiniCap with Povidone-Iodine Solution, item number 5C4466P, for hemodialysis.

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