The Recall Desk
SevereFDA (Devices)·Z-0563-2024·Announced 2024-01-03

Medline Nurse Training Kits Recalled for Sharp Tracheostomy Brush

Medline Industries recalls 550 educational nurse training kits due to sharp edges on tracheostomy brush components that can puncture tubing or cause injury, and bristles that may detach during or before 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: FDA Class I medical device recall with confirmed bristle detachment incidents and potential for user injury from sharp edges, though no actual injuries have been reported.

Plain-English summary

Medline Industries, LP is recalling two educational training kits: the Nurse Kit (SKU EDUC1025) and Nursing Tote Kit (SKU EDUC5056A). The tracheostomy brush component has a sharp edge at the tip that can potentially puncture tubing during use and/or cause user injury. Additionally, the brush bristles can detach prior to use in packaging and/or during use.

A total of 550 kits have been distributed nationwide throughout the United States, including Puerto Rico. International distribution also occurred to Canada, Panama, and the United Arab Emirates. The affected lot numbers are 22JDB315 and 22HDC340 for SKU EDUC1025, and 22HDC201 and 22HDA420 for SKU EDUC5056A.

The products are labeled as non-sterile devices 'For Training Purposes Only, Not For Human Use' and are intended for educational settings rather than clinical use.

The recalled product

Product
(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.
Manufacturer
MEDLINE INDUSTRIES, LP - Northfield
Hazard
  • sharp-edge
  • bristle-detachment

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 (2)

  • (1) EDUC1025 - Lot numbers 22JDB315 and 22HDC340
  • and (2) EDUC0506A - Lot numbers 22HDC201 and 22HDA420.

Distribution

Distributed nationwide across the United States.