FDA-Device2023-02-15Class II

TRACH PACK. Sterile Procedural Tray.

Hazard

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Affected count
28 cases (112 units)
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
TRACH PACK. Sterile Procedural Tray.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1061-2023

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