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U.S. Department of Health and Human Services

Class 1 Device Recall NORMOFLO

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  Class 1 Device Recall NORMOFLO see related information
Date Initiated by Firm August 06, 2021
Create Date September 03, 2021
Recall Status1 Open3, 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/
Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact Dave Halverson
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 2
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 and Original Applicant = SMITHS MEDICAL ASD, INC.