FDAFDA · Food and drugs·Recall number Z-0563-2024
(1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use.; and (2) Nursing Tote Kit, SKU #EDUC5056A, Case UPC 40195327153695, Non-sterile, For Training Purposes Only, Not For Human Use.
Published January 3, 2024 · Recall initiated: October 16, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The component tracheostomy brush has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, there have been incidents of the tracheostomy brush bristles detaching prior to use in the packaging and/or during use.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Distributor
- US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates.
- Lot
- (1) EDUC1025 - Lot numbers 22JDB315 and 22HDC340; and (2) EDUC0506A - Lot numbers 22HDC201 and 22HDA420.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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