Z-0594-2024Class I

Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE

Name: Z-0594-2024 Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Creator: Busse Hospital Disposables, Inc.
Published: 2023-11-30
License: https://open.fda.gov/license/

Busse Hospital Disposables / initiated 2023-11-30 / Open, Classified / root cause: manufacturing process

FDA source

Busse Hospital Disposables, Inc. began a recall of Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE on 2023-11-30. FDA classified it as Class I and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0594-2024
Classification: Class I
Status: Open, Classified
Initiated: 2023-11-30
Posted: 2024-01-03
Recalling firm: Busse Hospital Disposables
Product: Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Product code: NXA Tracheotomy Care Kit
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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]
Quantity in commerce: 240
Distribution: US Nationwide distribution.
Product codes and lots: UDI-DI 00849233011069 Lots 2210087 2210165 2310361

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0594-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0592-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-01-10	2024-01-03
Z-0593-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-01-10	2024-01-03
Z-0594-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-01-10	2024-01-03

Product code NXA

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)