FDA recall Z-0593-2024

Busse Hospital Disposables, Inc. · Class I · device

Product

Catalog No. 1443 DRESSING CHANGE 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.

Distribution

US Nationwide distribution.

Key facts

Status
Ongoing
Initiation date
2023-11-30
Report date
2024-01-10
Voluntary/Mandated
Voluntary: Firm initiated
Location
Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0593-2024