FDA Enforcement
Class I
Ongoing
Catalog No. 800 TRACHEOSTOMY CARE TRAY - STERILE -LATEX FREE
Recall: Z-0592-2024
·
Reported January 10, 2024
Enforcement
- Recall Number
- Z-0592-2024
- Event ID
- 93546
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Busse Hospital Disposables, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Report Date
- January 10, 2024
- Initiation Date
- November 30, 2023
- Classification Date
- January 3, 2024
- Address
- 75 Arkay Dr, N/A, Hauppauge, NY, 11788-3707, United States
Description
Catalog No. 800 TRACHEOSTOMY CARE 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.
Code Info
UDI-DI 00849233010000 Lots 2210099 2210135 2210337 2210377 2310181 2310233 2310291
Distribution
US Nationwide distribution.
Quantity
705