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MEDLINE INDUSTRIES, LP - Northfield recalls CRANIOTOMY PACK, Pack Number DYNJ46552O
Recalled September 18, 2024 · FDA recall Z-3069-2024 · 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. · FDA Class II
Units
188 units
Sold at
US: TX, IL, CA
Description
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.
Product
CRANIOTOMY PACK, Pack Number DYNJ46552O
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →