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MEDLINE INDUSTRIES, LP - Northfield recalls KIT PEDI CRANI LAMI, Pack Number DYNJ907372A

Recalled September 18, 2024 · FDA recall Z-3070-2024 · 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
485 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
KIT PEDI CRANI LAMI, Pack Number DYNJ907372A
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov