Skip to content
Recall Observatory FDA recall evidence

Device product

Direct Water feed Kit, Catalog#10373222

Z-1661-2015

March 05, 2015

Class II

Product summary

Firm
Siemens Medical Solutions Diagnostics
Event
Event 71022
Status
Terminated
Classification
Class II
Quantity
15 bottles
Official record key
device-enforcement:Z-1661-2015

Official wording

Reason: 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.

Code information: Direct Water Feed Kit - Product Code/Catalog #10373222

Distribution pattern: Worldwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.