Reported Jan 10, 2024 · Ongoing
Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
Busse Hospital Disposables, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Busse Hospital Disposables, Inc. · 75 Arkay Dr · Hauppauge, NY · 11788-3707
Is this the product you have?
- Catalog No. 1443 DRESSING CHANGE TRAY / STERILE - LATEX FREE
- Lot codes and dates
- UDI-DI 00849233010727 Lots 2210077 2210112 2310275 2310331
- Amount recalled
- 536
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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