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Recall Observatory FDA recall evidence

Device 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.

Z-0563-2024

October 16, 2023

Class I

Product summary

Firm
MEDLINE INDUSTRIES, LP - Northfield
Event
Event 93327
Status
Ongoing
Classification
Class I
Quantity
550 kits
Official record key
device-enforcement:Z-0563-2024

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

Distribution pattern: US Nationwide distribution including Puerto Rico. OUS (Foreign) distribution was made to Canada, Panama, and United Arab Emirates.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.