FDA Devices recall · Reported January 10, 2024
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
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 as…
Busse Hospital Disposables, Inc. recalled Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE - a critical-severity action.
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE was recalled by Busse Hospital Disposables, Inc. in January 10, 2024. Reason: Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist …. Check the official notice for the remedy. Verify recall #Z-0592-2024 with the FDA Devices before acting.
The recall
Busse Hospital Disposables, Inc. issued this critical-severity FDA Devices recall-Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist ….
- Critical
- severity level
- 705 units
- affected scope
- Class I
- classification
- January 10, 2024
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0592-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0592-2024) was formally reported on January 10, 2024, with the manufacturer initiating the action on November 30, 2023. It is classified under Critical severity (Class I), with a current status of Ongoing. Busse Hospital Disposables, Inc. is listed as the recalling firm, operating out of Hauppauge, NY. Federal records list the affected scope as 705.
The documented reason for this recall is: 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 g… Distribution data in the federal record shows the product reached: US Nationwide distribution.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,861 medical devices recalls on record
Of 88,001 recalls with an agency hazard classification, 19,020 are high severity, 64,468 moderate, and 4,513 low. A further 16,157 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | Z-0592-2024 |
| Date reported | January 10, 2024 |
| Date initiated | November 30, 2023 |
| Recalling firm | Busse Hospital Disposables, Inc. |
| Firm location | Hauppauge, NY |
| Affected scope | 705 |
| Distribution | US Nationwide distribution. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0592-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Methodology · Corrections · Archive as of August 2026