Catalog No. 9251R1, 9251R2, 9251R3 recallZ-0594-2024 · Busse Hospital Disposables, Inc. · initiated Nov 30, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Busse Hospital Disposables, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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 [email protected]
Recall details
- Recall number
- Z-0594-2024
- Status
- Open, Classified
- Initiated by the company
- Nov 30, 2023
- Posted by the FDA
- Jan 3, 2024
- Recalling firm
- Busse Hospital Disposables, Inc.
- Quantity
- 240
- Product code
- NXA
- Distribution
- US Nationwide distribution.
Product description
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Code information (models, lots, serial numbers)
UDI-DI 00849233011069 Lots 2210087 2210165 2310361
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Busse Hospital Disposables 9251Robert Busse & CO., Inc. · Tracheotomy Care Kit1 recall0 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 93546).
- Z-0592-2024 · Open, ClassifiedCatalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
- Z-0593-2024 · Open, ClassifiedCatalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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