Z-0594-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- January 10, 2024
- Initiation Date
- November 30, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 240
Product Description
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / 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 Pattern
US Nationwide distribution.
Code Information
UDI-DI 00849233011069 Lots 2210087 2210165 2310361