The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. 

Recalled Product 

• Product Names: Tracheostomy Care Kit, Dressing Change Kit, and Tracheostomy Care Set
• Product Codes: NXA, MCY – See Recall Database Entry:
  • Class 1 Device Recall Tracheostomy Care Set (fda.gov)
  • Class 1 Device Recall DRESSING CHANGE TRAY / STERILE LATEX FREE (fda.gov)
  • Class 1 Device Recall DRESSING CHANGE TRAY / STERILE LATEX FREE (fda.gov)
• Model Numbers: 
  • Catalog No. 800 TRACHEOSTOMY CARE TRAY
  • Catalog No. 1443 DRESSING CHANGE TRAY
  • Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET
• Distribution Dates: June 20, 2022 to November 7, 2023 
• Devices Recalled in the U.S.: 1706
• Date Initiated by Firm: November 14, 2023

Device Use 

Busse tracheostomy care trays and kits come sterile packaged and include commonly used components for the removal, cleaning and replacement of the trachea (windpipe) tube along with a dressing change, ensuring convenience and efficiency during medical procedures. 

Reason for Recall   

Busse Hospital Disposables is recalling their Tracheostomy Care Tray, Dressing Change Tray, and Tracheostomy Care Set in direct response to Nurse Assist LLC’s, November 6, 2023, recall of 0.9% sodium chloride irrigation USP and sterile water for irrigation USP, over sterility concerns. This is the only saline used in the Busse trays and kits. The recall doesn't affect the integrity of the other kit components. 

The use of affected trays or kits may cause serious adverse health consequences, including blood stream infections, urinary tract infections or respiratory infections and in the worst-case scenario sepsis and death. People who have certain health problems like weak immune systems, who are otherwise susceptible to infection or chronic lung diseases may be more at risk.

There have been no reports of injury or death.

Who May be Affected  

• Health care providers using Busse Tracheostomy Care trays or kits
• People who receive care using Busse Tracheostomy Care trays or kits

What to Do  

On November 21, 2023 and December 6, 2023 Busse Hospital Disposables sent all affected customers two URGENT: Medical Device Recall Notices. 

The letters requested customers to: 

• Destroy devices that have been shipped directly to customer facilities and identified as affected. 
• Using the form provided with this letter, document the quantity of the destroyed product(s) and provide a photograph of the items clearly displaying the lot number. Submit this information to Nurse Assist and send a copy to Busse. 
• Complete and submit to Busse the included Acknowledgement and Receipt Form regardless of having affected product or not.

Contact Information  

Customers in the U.S. with questions about this recall should contact Busse Hospital Disposables at 1-800-645-6526.

Additional Resources:  

• Class 1 Device Recall Tracheostomy Care Set (fda.gov)
• Class 1 Device Recall DRESSING CHANGE TRAY / STERILE LATEX FREE (fda.gov)
• Class 1 Device Recall DRESSING CHANGE TRAY / STERILE LATEX FREE (fda.gov)
• Recall of Certain Saline and Sterile Water Medical Products Associated with Nurse Assist: FDA Safety Communication | FDA 
• Busse Hospital Disposables Issues Nationwide Recall of Kits/Trays Containing Sterile Water Based Products Under Recall by Nurse Assist | FDA

How do I report a problem? 

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program using an online form, regular mail, or FAX.