Medical device recalls Moderate risk

Siemens Medical Solutions Diagnostics recalls Direct Water feed Kit, Catalog#10373222

Recall date
March 5, 2015
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1661-2015
FDA classification
Class II
Brand / firm
Siemens Medical Solutions Diagnostics
Sold / distributed
Worldwide Distribution.

Why it was recalled

The bottle assemblies were manufactured with a quality issue where in some cases the smaller diameter opening on both IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed, preventing the cap from closing or fastening securely to the bottle.

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

What was recalled

Direct Water feed Kit, Catalog#10373222

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