—#188711

Product

NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700

FDA product code: LGZ — Warmer, Thermal, Infusion Fluid
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K072080
Affected 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

Why it was 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.

Root cause (FDA determination)

Device Design

Action the firm took

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 fieldactions@smiths-medical.com.

Recalling firm

Firm: Smiths Medical ASD Inc.
Address: 6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

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

Timeline

Recall initiated: 2021-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #188711. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.