FDA Device recall Z-0563-2024
(1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use
- FDA Device
- Class I
- ongoing
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class I recall of (1) Nurse Kit, SKU #EDUC1025, Case UPC 40195327196647, Non-sterile, For Training Purposes Only, Not For Human Use by Medline Industries Northfield, citing 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 t….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0563-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-10-16 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
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.
Reason
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.
Identifiers
| upc | 40195327196647 |
|---|---|
| upc | 40195327153695 |
| code_info | (1) EDUC1025 - Lot numbers 22JDB315 and 22HDC340; and (2) EDUC0506A - Lot numbers 22HDC201 and 22HDA420. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0563-2024%22
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