Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE
Reported: January 10, 2024 Initiated: November 30, 2023 #Z-0594-2024
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.
Details
- Recalling Firm
- Busse Hospital Disposables, Inc.
- Units Affected
- 240
- Distribution
- US Nationwide distribution.
- Location
- Hauppauge, NY
Frequently Asked Questions
What product was recalled? ▼
Catalog No. 9251R1, 9251R2, 9251R3 TRACHEOSTOMY CARE SET / STERILE - LATEX FREE. Recalled by Busse Hospital Disposables, Inc.. Units affected: 240.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 10, 2024. Severity: Critical. Recall number: Z-0594-2024.
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