CLASS I ONGOING Device recall · Reported 10 Jan 2024 · FDA Enforcement Report
Catalog No. 9251R1, 9251R2, 9251R3 Tracheostomy Care SET / Sterile recalled
Busse Hospital Disposables is recalling Catalog No. 9251R1, 9251R2, 9251R3 Tracheostomy Care SET / Sterile, distributed nationwide in the US. The recall was initiated on 30 Nov 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0594-2024
- FDA event ID
- 93546
- Recalling firm
- Busse Hospital Disposables, Hauppauge, NY
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 30 Nov 2023
- FDA classified
- 3 Jan 2024
- Reported
- 10 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 30 Nov 2023 | Recall initiated by company | |
| 3 Jan 2024 | Classified by FDA | +34 days |
| 10 Jan 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Where it was distributed
US Nationwide distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
UDI-DI 00849233011069 Lots 2210087 2210165 2310361
Where was it sold?
US Nationwide distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 93546| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Catalog No. 1443 Dressing Change Tray / Sterile - Latex Free recalled | Busse Hospital Disposables | Sterility | Nationwide | |
| CLASS I | Catalog No. 800 Tracheostomy Care Tray - Sterile -Latex Free recalled | Busse Hospital Disposables | Sterility | Nationwide |
More recalls from Busse Hospital Disposables
All 63| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS I | Catalog No. 800 Tracheostomy Care Tray - Sterile -Latex Free recalled | Busse Hospital Disposables | Sterility | Nationwide |
| Device | CLASS I | Catalog No. 1443 Dressing Change Tray / Sterile - Latex Free recalled | Busse Hospital Disposables | Sterility | Nationwide |
| Device | CLASS II | Busse Spine Injection Tray-Intended as a nerve block recalled | Busse Hospital Disposables | Other | TX |
| Device | CLASS II | Busse Joint Injection Tray -Intended as a nerve block recalled | Busse Hospital Disposables | Other | TX |
| Device | CLASS II | Male SS Pellet Insertion Tray recalled by Busse Hospital Disposables | Busse Hospital Disposables | Other | Nationwide |
Other Other Medical Devices recalls
All 13,778| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Citric Complete Dry Citric Acid Concentrate recalled | Nipro Renal Soultions USA | Other | Nationwide |
| Device | CLASS I | Kit: Epidural/Pain TQC 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | Halyard IV Start Kit Non-Sterile recalled by Avid Medical | Avid Medical | Sterility | Nationwide |
| Device | CLASS I | Kit: Single Shot Epidural 20/Cs recalled by Medical Action Industries | Medical Action Industries Inc. 306 | Sterility | 6 states |
| Device | CLASS II | AMS Convenience Kit: Dsaek Pack - RX recalled | Windstone Medical Packaging | Device Malfunction | Nationwide |