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U.S. Department of Health and Human Services

Class 1 Device Recall HUDSON RCI Addipak

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  Class 1 Device Recall HUDSON RCI Addipak see related information
Date Initiated by Firm August 04, 2023
Date Posted September 14, 2023
Recall Status1 Open3, Classified
Recall Number Z-2514-2023
Recall Event ID 92834
510(K)Number K142153  
Product Classification Nebulizer (direct patient interface) - Product Code CAF
Product HUDSON RCI Addipak, UNIT DOSE VIALS, 5mL Sterile 0.9% NaCl Solution for Inhalation USP. REF RHUD59U
Code Information UDI/DI 140267047147818, Lot code 3B085
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
886-359-1704
Manufacturer Reason
for Recall		 Product dispositioned for scrap for sterility failure investigation that was inadvertently shipped to customers.
FDA Determined
Cause 2		 Process control
Action Medline issued a recall notice on 08/04/2023 to its consignees by mail and email. The notice explained the problem with the product, risk to use, and requested all affected product be destroyed. Distributors are directed to notify their customers and have the customers document and destroy any affected product. This should be included the customers quantities on the distributor response form.
Quantity in Commerce 18,000 units
Distribution US Nationwide distribution.
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 = CAF and Original Applicant = Teleflex Medical, Inc.
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