FDA-Device2015-06-03Class II

Direct Water feed Kit, Catalog#10373222

Siemens Medical Solutions Diagnostics
Hazard

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.

Sold states
Worldwide Distribution.
Affected count
15 bottles
Manufactured in
62 Flanders-Bartley Rd, Flanders, NJ, United States
Products
Direct Water feed Kit, Catalog#10373222

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1661-2015

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