Busse Hospital Disposables recalls sterile dressing change trays with specific lots due to potential blood stream infections from inadequate sterility assurance.
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.
Busse Hospital Disposables is recalling sterile dressing change trays that may not meet sterility standards. Using these trays could lead to infections like blood stream infections, urinary tract infections, or respiratory infections in patients.
The recalled trays were manufactured without meeting the required sterility assurance level (SAL) of 10^-6. This means the product might not be sterile enough to prevent infections when used in medical procedures. If the product is used without proper sterility, it could introduce harmful bacteria into the patient's body.
Patients receiving care using the recalled dressing change trays are at risk. Healthcare workers using these trays for sterile procedures may also be affected.
Check for the catalog number 1443 DRESSING CHANGE TRAY / STER: LATEX FREE. The affected lots are 2210077, 2210112, 2310275, and 2310331.
Immediately stop using any recalled dressing change trays as they may cause infections.
The trays may not meet the required sterility assurance level (SAL) of 10^-6, increasing the risk of blood stream infections, urinary tract infections, or respiratory infections in patients.
Affected lots are 2210077, 2210112, 2310275, and 2310331.
Look for the catalog number 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE and the affected lots listed above.
We’ve drafted a message you can send Busse Hospital Disposables to request your refund or repair — edit it as you like.
Subject: Recall Z-0593-2024 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-0593-2024 from Busse Hospital Disposables. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
