Device product
(1) Nursing Skills kit, SKU #EDUC05038B, Case UPC 40195327019878, Non-sterile, For Training Purposes Only, Not For Human Use.
Z-0562-2024
Product summary
- Event
- Event 93327
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 172 kits
- Official record key
device-enforcement:Z-0562-2024
Official wording
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.
Code information: (1) EDUC05038B - Lot numbers 22IDA181, 22FDB543, and 22ADB550, case UPC40195327019878;
Distribution pattern: US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates.
Derived failure modes
-
Unknown
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.