Catalog No — Class I medical device recall Z-0592-2024
Ongoing recall by Busse Hospital Disposables, Inc., reported 2024-01-10, distributed nationwide. Firm is recalling all kits containing recalled lots of Nurse Assist Sterile 0.9% Normal Saline. Nurse Assist i
| Recall number | Z-0592-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Busse Hospital Disposables, Inc., Hauppauge, NY, United States |
| Recall initiated | 2023-11-30 |
| Classified | 2024-01-03 |
| Reported by FDA | 2024-01-10 |
| Distributed | Nationwide (US) |
| Quantity | 705 |
| Reason classes | sterility |
| UPC / GTIN / UDI-DI | 00849233010000 |
| Lot numbers | 2210099, 2210135, 2210337, 2210377, 2310181, 2310233, 2310291 |
| Model numbers | 800 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0592-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.