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MEDLINE INDUSTRIES, LP - Northfield recalls (1) Medline Sterile Hand Pack, Item DYNJ63380A, 3 kits per case, contains BD Chloraprep Hi-Lite Orange, 26 mL Applicator
Recalled March 1, 2023 · FDA recall Z-1163-2023 · 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. · FDA Class II
Units
1,689 trays
Sold at
US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution.
Description
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
Product
(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.
Manufacturer(s)
MEDLINE INDUSTRIES, LP - Northfield
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →