FDA-Device2023-03-01Class II
(1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS; (2) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546D, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS.
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
720 trays
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
(1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS; (2) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546D, 6 kits per case, contains BD Chloraprep Hi-Lite Orange, 10.5 mL Applicator, Vendor PN: 930715NS.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1162-2023Don't want to check this manually?
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