CLASS II Device recall · Reported 3 Jun 2015 · FDA Enforcement Report

Direct Water feed Kit recalled by Siemens Medical Solutions

Siemens Medical Solutions Diagnostics is recalling Direct Water feed Kit. The recall was initiated on 5 Mar 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesDirect Water Feed Kit - Product Code/Catalog #10373222

Quantity recalled15 bottles

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1661-2015
FDA event ID: 71022
Recalling firm: Siemens Medical Solutions Diagnostics, Flanders, NJ
Classification: Class II
Status: Terminated
Recall initiated: 5 Mar 2015
FDA classified: 23 May 2015
Reported: 3 Jun 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

5 Mar 2015	Recall initiated by company
23 May 2015	Classified by FDA	+79 days
3 Jun 2015	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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.

Product as listed by the FDA

Direct Water feed Kit, Catalog#10373222

Where it was distributed

Worldwide Distribution.

Questions about this recall

Is Direct Water feed Kit recalled?

Yes. Siemens Medical Solutions Diagnostics recalled Direct Water feed Kit on 5 Mar 2015. The recall is Class II and its status is Terminated. Recall number Z-1661-2015.

Why was it recalled?

Which lots are affected?

Direct Water Feed Kit - Product Code/Catalog #10373222

Where was it sold?

Worldwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Reported	Class	Recall	Company	Reason	Where
3 Jun 2015Device	CLASS II	Liquid Waste recalled by Siemens Medical Solutions	Siemens Medical Solutions Diagnostics	Potency & Assay	NJ
3 Jun 2015Device	CLASS II	Liquid Waste Bottle Kit recalled by Siemens Medical Solutions	Siemens Medical Solutions Diagnostics	Potency & Assay	NJ
3 Jun 2015Device	CLASS II	Water bottles, Catalog#10380062, #10291586. The Immulite recalled	Siemens Medical Solutions Diagnostics	Potency & Assay	NJ
3 Jun 2015Device	CLASS II	Water Feed Kit recalled by Siemens Medical Solutions	Siemens Medical Solutions Diagnostics	Potency & Assay	NJ
3 Jun 2015Device	CLASS II	Accessory Kit recalled by Siemens Medical Solutions	Siemens Medical Solutions Diagnostics	Potency & Assay	NJ

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