FDA-Device2024-09-18Class II
KIT PEDI CRANI LAMI, Pack Number DYNJ907372A
MEDLINE INDUSTRIES, LP - Northfield
Hazard
A non-sterile Mastisol component, which was not labeled as being sterile or non-sterile, was placed in the non-sterile portion of certain sterile convenience kits and distributed. In the event that the user assumes sterility during its use, there is an increased risk of patient infection.
Sold states
US: TX, IL, CA
Affected count
485 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
KIT PEDI CRANI LAMI, Pack Number DYNJ907372A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3070-2024Don't want to check this manually?
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