FDA-Device2023-03-01Class II
(1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS; and (2) Medline Sterile Hand Pack, Item DYNJ63380C, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS.
MEDLINE INDUSTRIES, LP - Northfield
Hazard
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
Sold states
US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution.
Affected count
1,689 trays
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
(1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS; and (2) Medline Sterile Hand Pack, Item DYNJ63380C, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator, Vendor PN: 930815NS.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1163-2023Don't want to check this manually?
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