FDA-Device2024-09-18Class II
ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A
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
315 units
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
ANESTHESIA TURNOVER KIT, Pack Number DYNJAA0377A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3072-2024Don't want to check this manually?
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