—#203988

Product

(1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.

FDA product code: LRO — General Surgery Tray
Device class: Class 2
Medical specialty: General, Plastic Surgery
Affected lot / code info: (1) EDUC05038B - Lot numbers 22IDA181, 22FDB543, and 22ADB550, case UPC40195327019878;

Why it was recalled

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates.

Timeline

Recall initiated: 2023-10-16
Posted by FDA: 2023-12-22
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #203988. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.