The Recall Desk
SevereFDA (Devices)·Z-0561-2024·Announced 2024-01-03

Medline Tracheostomy Care Kits Recalled for Sharp Brush and Bristle Detachment

Medline is recalling 620,735 tracheostomy care kits because the brush component has a sharp edge that can puncture tubing and injure users, and bristles can detach during use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA classification of Class I requires a minimum severity score of 4. While the source does not report actual injuries or deaths, the real incidents of bristle detachment combined with the serious potential for airway tubing puncture during a critical medical procedure justify a Severe rating.

Plain-English summary

Medline Industries is recalling six models of sterile and non-sterile tracheostomy care kits distributed nationwide in the US, Puerto Rico, Canada, Panama, and the United Arab Emirates. A total of 620,735 kits are affected: Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter (REF DYND40580), Medline Tracheostomy Clean and Care Tray (REF DYND4061030), Medline Basic Tracheostomy Care Kit (REF CC3T4691A), Medline Tracheostomy Care Kit with Glove (REF CC4681A), Medline Mini Tracheostomy Care Kit (REF CC3T3030A), and Medline Mini Tracheostomy Care Kit Non-Sterile (REF DYND40622).

The tracheostomy brush component has a sharp edge at its tip that can potentially puncture tubing during use and/or cause injury to users. Additionally, there have been reported incidents where the brush bristles detached prior to use while still in packaging and/or during clinical use.

Patients and healthcare facilities using affected kits should immediately stop use and contact Medline for instructions. Specific lot numbers for each product model are detailed in the FDA recall database. If tubing puncture or bristle detachment is observed, the affected kit should not be used.

The recalled product

Product
Tracheostomy care kits: (1) Medline Tracheostomy Clean and Care Tray with 14 Fr Suction Catheter, REF DYND40580, Sterile; (2) Medline Tracheostomy Clean and Care Tray, REF DYND4061030, Sterile; (3) Medline Basic Tracheostomy Care Kit, REF CC3T4691A, Sterile; (4) Medli
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Category
Medical Device — Respiratory Care
Hazard
Affected units
620,735

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • (1) DYND40580 - UDI 10080196032761
  • lot numbers: 6052203006
  • 6052203022
  • 6052204005
  • 6052204010
  • 6052205024
  • 6052206003
  • 6052206010
  • 6052206011
  • 6052206020
  • 6052206021
  • 6052207009
  • 6052207013
  • 6052207014
  • 6052207015
  • 6052208021
  • 6052208022
  • 6052209009
  • 6052209025
  • 6052209026

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Related recalls

Same manufacturer · MEDLINE INDUSTRIES, LP - Northfield

See all →

Same hazard · sharp edge

See all →