Class 1 Device Recall NORMOFLO

• Date Initiated by Firm: August 06, 2021
• Create Date: September 03, 2021
• Recall Status: Open, Classified
• Recall Number: Z-2377-2021
• Recall Event ID: 88455
• 510(K)Number: K072080
• Product Classification: Warmer, thermal, infusion fluid - Product Code LGZ
• Product: NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700
• 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
• Recalling Firm/ Manufacturer: Smiths Medical ASD Inc.; 6000 Nathan Ln N; Minneapolis MN 55442-1690
• For Additional Information Contact: Dave Halverson; 763-383-3072
• Manufacturer 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.
• FDA Determined 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. 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.
• Quantity in Commerce: 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = LGZ