Z-2377-2021 Class I Ongoing
FDA device recall Z-2377-2021 was initiated by Smiths Medical ASD Inc. on August 6, 2021 and is designated Class I. 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. The recall status is ongoing. Affected quantity: 519,250.
Recall Details
- Product Type
- Devices
- Report Date
- September 15, 2021
- Initiation Date
- August 6, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 519,250
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.
Distribution Pattern
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
Code Information
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