FDA-Device2023-02-22Class II
Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B
MEDLINE INDUSTRIES, LP - Northfield
Hazard
The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.
Sold states
Nationwide
Affected count
60 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Surgical convenience kits labeled as: MEDLINE BREAST BIOPSY KIT, Reorder Number DYNDA1224B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1114-2023Don't want to check this manually?
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