Medical device recalls Moderate risk

Baxter Healthcare Corp. recalls Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

Recall date
October 6, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0194-2016
FDA classification
Class II
Brand / firm
Baxter Healthcare Corp.
Sold / distributed
US Distribution and Internationally to Canada.

Why it was recalled

Leakage from the inlet port of the 15L Cycler Drainage Bags.

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

What was recalled

Baxter 15L Cycler Drainage Bag Sterile, nonpyrogenic fluid path

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