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U.S. Department of Health and Human Services

Class 1 Device Recall Medline

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  Class 1 Device Recall Medline see related information
Date Initiated by Firm October 16, 2023
Date Posted December 22, 2023
Recall Status1 Open3, Classified
Recall Number Z-0563-2024
Recall Event ID 93327
Product Classification Patient personal hygiene kit - Product Code NSB
Product (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and
(2) Nursing Tote Kit, SKU #EDUC5056A, Case UPC 40195327153695, Non-sterile, For Training Purposes Only, Not For Human Use.
Code Information (1) EDUC1025 - Lot numbers 22JDB315 and 22HDC340; and (2) EDUC0506A - Lot numbers 22HDC201 and 22HDA420.
Recalling Firm/
Manufacturer		 MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
For Additional Information Contact Karin Johnson
886-369-1704
Manufacturer Reason
for Recall		 The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.
FDA Determined
Cause 2		 Under Investigation by firm
Action The recalling firm issued "MEDICAL DEVICE RECALL" letters dated 10/16/2023 via first class mail and email explaining the reason for recall and the required actions that needed to be taken. The actions for consignees to take included checking their stock for the affected item numbers and affected lot numbers which are located within the recall portal; using the link, https://recalls.medline.com, provided in the letter to complete the response form with the quantity of affected product in inventory; and destroy the affected inventory for credit. If the consignee is a distributor who has resold or transferred the product to another company or individual, they are to notify them of this recall and document the amount of product their customer destroyed on their (the distributor) response form. If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com.
Quantity in Commerce 550 kits
Distribution US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates.
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.
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