FDA-Device2023-02-22Class II
Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD; b) MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
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
981 units
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
Surgical convenience kits labeled as: a) MEDLINE PERF. ASSOC. CUT DOWN TRAY, Reorder Number BM17BAD; b) MEDLINE ARM/MINOR DRAPE CSTM, Reorder Number DYNJCD0063
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1120-2023Don't want to check this manually?
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