FDA-Device2023-02-15Class II

UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray

MEDLINE INDUSTRIES, LP - Northfield
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
20 cases (120 units)
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
UNIVERSAL CORE DR RUNNELS PACK. Sterile Procedural Tray

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1064-2023

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