The Recall Desk
ModerateFDA (Devices)·Z-1661-2015·Announced 2015-06-03

Siemens Medical Solutions Recalls Direct Water Feed Kits Due to Quality Issue

Siemens Medical Solutions Diagnostics is recalling Direct Water feed Kits because a quality issue may prevent bottle caps from closing securely.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the defect is a manufacturing quality issue that does not explicitly report injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Siemens Medical Solutions Diagnostics is recalling 15 bottles of Direct Water feed Kits, Catalog #10373222. The product was distributed worldwide.

The recall was initiated because the bottle assemblies were manufactured with a quality issue. In some cases, the smaller diameter opening on the IMMULITE 2000 and IMMULITE 2000XPi Water Bottles and Liquid Waste Bottles is undersized and/or deformed. This defect prevents the cap from closing or fastening securely to the bottle.

The source text does not specify specific actions for consumers or healthcare providers, nor does it report any injuries or illnesses associated with this defect.

The recalled product

Product
Direct Water feed Kit, Catalog#10373222
Affected units
15

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Direct Water Feed Kit - Product Code/Catalog #10373222

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 6 recalled by Siemens Medical Solutions Diagnostics under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 6 products in this recall →

Same manufacturer · Siemens Medical Solutions Diagnostics

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