Tracheostomy Care Tray (Busse) – Saline Lot Recall (2023)
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Brand
Busse Hospital Disposables, Inc.
Lot Codes / Batch Numbers
UDI-DI 00849233010000 Lots 2210099 2210135 2210337 2210377 2310181 2310233 2310291
Products Sold
UDI-DI 00849233010000 Lots 2210099 2210135 2210337 2210377 2310181 2310233 2310291
Busse Hospital Disposables, Inc. is recalling Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE due to Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for wh. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist identified product in distribution for which the required sterility assurance level (SAL) of 10^-6 cannot be guaranteed. Risks to patients if product is used include blood stream infections, urinary tract infections, or respiratory infections; in the worst-case scenario, there is risk of sepsis or death.
Recommended Action
Per FDA guidance
On November 21, 2023, the firm notified affected distributors via URGENT MEDICAL DEVICE RECALL letters. Customers were asked to segregate and destroy any affected kits. Distributors should also inform their customers of the recall. Customers should return any affected product to their distributor. For questions, email NurseAssistRecall@busseinc.com
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026