Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile

FDA device recall Z-0561-2024 · posted 2023-12-22 · Open, Classified

Recall details

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

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.

Action taken

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.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

OGV

Quantity affected

620,735 kits

Distribution

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

Date initiated

2023-10-16

Date posted

2023-12-22

Location

Northfield, IL