NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
Reported: September 15, 2021 Initiated: August 6, 2021 #Z-2377-2021
Product Description
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
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.
Details
- Recalling Firm
- Smiths Medical ASD Inc.
- Units Affected
- 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
- Location
- Minneapolis, MN
Frequently Asked Questions
What product was recalled? ▼
NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700. Recalled by Smiths Medical ASD Inc.. Units affected: 519,250.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on September 15, 2021. Severity: Critical. Recall number: Z-2377-2021.
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