NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Summary
The FDA issued a Class I for NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-50 by Smiths Medical ASD Inc.. Reason: There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration o.
Details
Source
Device Recall
External ID
Z-2377-2021
Action Date
2021-09-15
Status
Ongoing
Category
device
Product Description
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Lot/Code Info: 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
Quantity Affected: 519,250
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.
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
Type: Voluntary: Firm initiated
Recall Initiated: 2021-08-06
Company
Minneapolis, MN
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 147 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Smiths Medical ASD Inc. has 164 FDA actions in our database, including 162 recalls and 2 clearances.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Smiths Medical ASD Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Smiths Medical ASD Inc. have FDA actions?
Smiths Medical ASD Inc. has 164 FDA actions in our database, including 162 recalls and 2 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2377-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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