FDA-Device2024-01-03Class I
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) Medline Tracheostomy Care Kit with Glove, REF CC4681A, Sterile; (5) Medline Mini Tracheostomy Care Kit, REF CC3T3030A, Sterile; and (6) Medline Mini Tracheostomy Care Kit, REF DYND40622, Non-sterile.
MEDLINE INDUSTRIES, LP - Northfield
Hazard
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.
Sold states
US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates.
Affected count
620,735 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
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) Medline Tracheostomy Care Kit with Glove, REF CC4681A, Sterile; (5) Medline Mini Tracheostomy Care Kit, REF CC3T3030A, Sterile; and (6) Medline Mini Tracheostomy Care Kit, REF DYND40622, Non-sterile.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0561-2024Don't want to check this manually?
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