Recall Z-2376-2021 ยท LGZ Warmer, Thermal, Infusion Fluid
Smiths Medical ASD Inc.
NORMOFLO Irrigation Fluid Warmer Models H-1100 and H-1129
| Date | Aug 6, 2021 |
| Status | Open, Classified |
| Reason | 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 | 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. Distrib |
| Quantity | 913 |
| 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, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072080 | NORMOFLO IRRIGATION FLUID WARMER, MODELS H-1100, H-1129, NORMOFLO IRRIGATION WARMING SET, MODELS, IR-40, IR-500, IR-600, Smiths Medical Asd, Inc., Jun 2, 2008 |