The Recall Desk
SevereFDA (Devices)·Z-0562-2024·Announced 2024-01-03

Medline Nursing Skills Kit: Tracheostomy Brush Sharp Edge and Bristle Defect

Medline is recalling 172 Nursing Skills kits due to defects in the tracheostomy brush component. The brush has a sharp edge that can puncture tubing and cause user injury, and bristles may detach during use.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class I recall, which mandates a minimum severity score of 4. Although no injuries or illnesses have been reported in the source text, the documented defects—sharp edges capable of puncturing tubing and bristle detachment—present direct injury risks to users.

Plain-English summary

Medline Industries, LP is recalling 172 Nursing Skills kits (SKU #EDUC05038B, Case UPC 40195327019878) containing tracheostomy brush components with manufacturing defects. The kits were distributed nationwide in the United States, Puerto Rico, Canada, Panama, and the United Arab Emirates. Affected lot numbers are 22IDA181, 22FDB543, and 22ADB550.

The tracheostomy brush component in the recalled kits has a sharp edge at the tip that can puncture tubing during use and potentially cause user injury. Additionally, incidents have been reported of brush bristles detaching prior to use or during use.

These products are labeled as training devices and are not intended for human use. Individuals and institutions that have received kits with the affected lot numbers should verify their inventory and take appropriate action if they possess affected products.

The recalled product

Product
(1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • sharp-edge
  • bristle-detachment
  • puncture-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • (1) EDUC05038B - Lot numbers 22IDA181
  • 22FDB543
  • and 22ADB550
  • case UPC40195327019878

Distribution

Distributed nationwide across the United States.