Recall Z-0592-2024— Busse Hospital Disposables, Inc.
Class I · Ongoing
Class I FDA medical device recall by Busse Hospital Disposables, Inc., initiated 2023-11-30. FDA's recall record names no specific 510(k) clearance for this event. Product: 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..
- Recalling firm
- Busse Hospital Disposables, Inc.
- Classification
- Class I
- Status
- Ongoing
- Initiated
- 2023-11-30
- Firm location
- Hauppauge, NY, United States
Product description
Catalog No. 800 TRACHEOSTOMY CARE 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.