MEDLINE INDUSTRIES, LP - Northfield: (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

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.

Details from the source

Reason for recall: 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. Distribution: US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates. Quantity: 550 kits Lot/code info: (1) EDUC1025 - Lot numbers 22JDB315 and 22HDC340; and (2) EDUC0506A - Lot numbers 22HDC201 and 22HDA420.

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.