CLASS I ONGOING Device recall · Reported 15 Sep 2021 · FDA Enforcement Report

Normoflo Irrigation Fluid Warmer recalled by Smiths Medical ASD

Smiths Medical ASD is recalling Normoflo Irrigation Fluid Warmer, distributed nationwide in the US. The recall was initiated on 6 Aug 2021 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesModel H-1100: Product Codes CON-H1100, H-1100, H-1100-ES-115V, H-1100-ES-230V, H-1100-FR-230V, H-1100-INT-230, H-1100-IT-230V, H-1100-NL-230V H-1100-SV-230V, H-1100-UK-230 Model H-1129: Product Code H-1129

Quantity recalled913

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-2376-2021
FDA event ID: 88455
Recalling firm: Smiths Medical ASD, Minneapolis, MN
Classification: Class I
Status: Ongoing
Recall initiated: 6 Aug 2021
FDA classified: 3 Sep 2021
Reported: 15 Sep 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

6 Aug 2021	Recall initiated by company
3 Sep 2021	Classified by FDA	+28 days
15 Sep 2021	Published in enforcement report	+12 days

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

Reason for recall

There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.

Product as listed by the FDA

NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129

Where it was distributed

US Nationwide Distribution and PR OUS distribution in - Austria, Australia, Belgium, Switzerland, Canada, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary, Ireland, Italy, Kuwait, Luxembourg, Netherlands, New Zealand, Panama, Poland, Portugal, Sweden, Turkey, Venezuela, South Africa

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.

Which lots are affected?

Model H-1100: Product Codes CON-H1100, H-1100, H-1100-ES-115V, H-1100-ES-230V, H-1100-FR-230V, H-1100-INT-230, H-1100-IT-230V, H-1100-NL-230V H-1100-SV-230V, H-1100-UK-230 Model H-1129: Product Code H-1129

Where was it sold?

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 88455

This product is part of a recall event; the main page for the event is Normoflo Irrigation Warming administration set (disposable) recalled.

Reported	Class	Recall	Company	Reason	Where
15 Sep 2021	CLASS I	Normoflo Irrigation Warming administration set (disposable) recalled	Smiths Medical ASD	Other	Nationwide

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