Device product

Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE

Z-0593-2024

November 30, 2023

Class I

Product summary

Firm: Busse Hospital Disposables, Inc.
Event: Event 93546
Status: Ongoing
Classification: Class I
Quantity: 536
Official record key: device-enforcement:Z-0593-2024

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 00849233010727 Lots 2210077 2210112 2310275 2310331

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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.