FDA Device recall Z-0593-2024
Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
- FDA Device
- Class I
- ongoing
- Published 2024-01-10
On 2024-01-10 the FDA classified a Class I recall of Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE by Busse Hospital Disposables, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0593-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-11-30 |
| Published | 2024-01-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Busse Hospital Disposables |
| Distribution | US |
Product
Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
Reason
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.
Identifiers
| code_info | UDI-DI 00849233010727 Lots 2210077 2210112 2310275 2310331 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0593-2024%22
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