Z-2377-2021Class I

NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B...

Name: Z-2377-2021 NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B...
Creator: Smiths Medical ASD Inc.
Published: 2021-08-06
License: https://open.fda.gov/license/

Abbott Medical / initiated 2021-08-06 / Open, Classified / root cause: design

FDA source

Smiths Medical ASD Inc. began a recall of NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700 on 2021-08-06. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2377-2021
Classification: Class I
Status: Open, Classified
Initiated: 2021-08-06
Posted: 2021-09-03
Recalling firm: Abbott Medical
Product: NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Product code: LGZ Warmer, Thermal, Infusion Fluid
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.
Root cause tag: design
FDA root cause: Device Design
Action: Smiths Medical sent an Urgent Medical Device Recall Notice and attachments dated August 13, 2021 to all affected customers. The letter instructed all customers who purchased affected devices listed in the table on page 1 of the Urgent Medical Device Recall Notice must identify any of the affected products within their possession and refer to the detailed instructions on pages 2 and 3 of the notice. Distributors will be instructed to immediately forward a copy of the Urgent Medical Device Recall Notice and attachments to any customers to whom they have distributed affected product. Distributors will also be instructed to request that customers to who they have distributed affected product complete the Response Form and return it to the distributor. Distributors will indicate their identity as the distributor and document the consignees name and address. Questions regarding this recall notification may be forwarded to [email protected].
Quantity in commerce: 519,250
Distribution: 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
Product codes and lots: Model IR-40: Product Code IR-40 Model IR-500: Product Code IR-500 Model IR-600: Product Code IR-600 Model IRI-600: Product Code IRI-600 Model IRI-600B: Product Code IRI-600B Model IR-700: Product Code IR-700

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2377-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2376-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-09-15	2021-09-03
Z-2377-2021	Class I	Ongoing	Voluntary: Firm initiated	2021-09-15	2021-09-03

Product code LGZ

K072080Class IINormoflo Irrigation Fluid Warmer, Models H-1100, H-1129, Normoflo Irrigation Warming Set, Models, Ir-40, Ir-500, Ir-600,Smiths Medical Asd, Inc. / cleared 2008-06-02

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)