Food, drugs, devices › Busse Hospital Disposables, Inc.
Device recall: Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Busse Hospital Disposables, Inc. (Hauppauge, NY) initiated this device recall on 30 Nov 2023; FDA lists 3 product records under event 93546, classified Class I.
FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 10% of the 917 device enforcement events initiated in 2023 carry the same class.
Status: Ongoing. Initiation: voluntary: firm initiated. Busse Hospital Disposables, Inc. has 3 enforcement events on this register, with a median of 3 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Busse Hospital Disposables, Inc., Hauppauge, NY.
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…"
Distribution
"US Nationwide distribution."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-0592-2024 | Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE | 705 | Class I | Ongoing | 10 Jan 2024 |
| Z-0593-2024 | Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE | 536 | Class I | Ongoing | 10 Jan 2024 |
| Z-0594-2024 | Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE | 240 | Class I | Ongoing | 10 Jan 2024 |
Context
Other enforcement events for Busse Hospital Disposables, Inc.
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 21 Oct 2022 | Busse JOINT INJECTION TRAY -Intended as a nerve block REF No. 8561 R1 | Device | Class II | 2 |
| 22 Feb 2022 | I.V. Start Kit - Tegaderm Dressing - Catheter Securement - Prevantics Catalog Number: 822 | Device | Class II | 58 |
All 3 events for Busse Hospital Disposables, Inc.
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall 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 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…"
What does Class I mean?
FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide distribution."
Is the recall still ongoing?
FDA lists the status as Ongoing. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.