CLASS I ONGOING Device recall · Reported 3 Jan 2024 · FDA Enforcement Report
Nursing Skills kit recalled by MEDLINE INDUSTRIES, LP
Medline Industries LP - Northfield is recalling Nursing Skills kit, distributed nationwide in the US. The recall was initiated on 16 Oct 2023 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0562-2024
- FDA event ID
- 93327
- Recalling firm
- Medline Industries LP - Northfield, Northfield, IL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 16 Oct 2023
- FDA classified
- 22 Dec 2023
- Reported
- 3 Jan 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Other Medical Devices
Timeline
| 16 Oct 2023 | Recall initiated by company | |
| 22 Dec 2023 | Classified by FDA | +67 days |
| 3 Jan 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
(1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.
Where it was distributed
US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
(1) EDUC05038B - Lot numbers 22IDA181, 22FDB543, and 22ADB550, case UPC40195327019878;
Where was it sold?
US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 93327This product is part of a recall event; the main page for the event is Tracheostomy care kits: Medline Tracheostomy Clean recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Tracheostomy care kits: Medline Tracheostomy Clean recalled | Medline Industries LP - Northfield | Packaging Defects | Nationwide | |
| CLASS I | Nurse Kit recalled by MEDLINE INDUSTRIES, LP | Medline Industries LP - Northfield | Packaging Defects | Nationwide |
More recalls from Medline Industries LP - Northfield
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|---|---|---|---|---|---|
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline medical convenience kits labeled as recalled | Medline Industries LP - Northfield | Device Malfunction | 6 states |
| Device | CLASS I | Medline ReNewal Reprocessed St. Jude Medical Response recalled | Medline Industries LP - Northfield | Particulate Matter | Nationwide |
| Device | CLASS II | The Medline General Surgery Tray is customized to meet recalled | Medline Industries LP - Northfield | Sterility | Nationwide |
| Device | CLASS II | Medline Kits containing BD SureStep Foley Tray Systems recalled | Medline Industries LP - Northfield | Labeling Errors | FL, IL |
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