Busse Hospital Disposables recalls sterile tracheostomy care sets with specific catalog numbers due to potential infection risks 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 tracheostomy care sets that may not meet sterility standards. Using these kits could lead to serious infections like sepsis or death in patients.
The recalled kits failed to guarantee a sterility level of 10^-6, meaning they could contain contaminants. If used, they might cause bloodstream infections, urinary tract infections, or respiratory infections, potentially leading to sepsis or death.
Patients using tracheostomy care sets with catalog numbers 9251R1, 9251R2, or 9251R3 are at risk. Healthcare providers and patients receiving these kits are most vulnerable.
Check for catalog numbers 9251R1, 9251R2, or 9251R3 on the tracheostomy care sets. The product was sold with specific lot numbers: 2210087, 2210165, and 2310361.
Immediately stop using any recalled tracheostomy care sets with the specified catalog numbers and lot numbers.
Using these kits could lead to bloodstream infections, urinary tract infections, or respiratory infections, potentially causing sepsis or death.
Catalog numbers 9251R1, 9251R2, and 9251R3 are affected.
Lot numbers 2210087, 2210165, and 2310361 are included in this recall.
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-0594-2024 — Busse Hospital Disposables Busse Hospital Disposables Hello, I own a Busse Hospital Disposables that is covered by recall Z-0594-2024 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.
