FDA-Device2023-02-08Class II
Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Potential for sterile blades, within non-sterile SPT kits containing the blades, to puncture the outer foil layer causing a breach in the sterile packaging.
Sold states
US Nationwide distribution in the states of AR, MD, WA, WI.
Affected count
216 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Non-sterile procedural trays labeled as ORTHO TRAUMA, 1 per case
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1033-2023Don't want to check this manually?
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