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
- Hazard
- sharp-edge
- bristle-detachment
- tubing-puncture
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.
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