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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- Siemens Medical Solutions Diagnostics
- 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 →Related recalls
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- ModerateSiemens Liquid Waste Bottle Kit Recalled for Defective Bottle Openings
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