Device product
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Z-0592-2024
Product summary
- Event
- Event 93546
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 705
- Official record key
device-enforcement:Z-0592-2024
Official wording
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.
Code information: UDI-DI 00849233010000 Lots 2210099 2210135 2210337 2210377 2310181 2310233 2310291
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.