(1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human
Summary
The FDA issued a Class I for (1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, F by MEDLINE INDUSTRIES, LP - Northfield. 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, .
Details
Source
Device Recall
External ID
Z-0562-2024
Action Date
2024-01-03
Status
Ongoing
Category
device
Product Description
(1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.
Lot/Code Info: (1) EDUC05038B - Lot numbers 22IDA181, 22FDB543, and 22ADB550, case UPC40195327019878;
Quantity Affected: 172 kits
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-10-16
Company
Northfield, IL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 94 device recalls issued in the same week, part of 413 device-related FDA actions this month.
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (MEDLINE INDUSTRIES, LP - Northfield) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does MEDLINE INDUSTRIES, LP - Northfield have FDA actions?
MEDLINE INDUSTRIES, LP - Northfield has 822 FDA actions in our database, including 822 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0562-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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