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FDA (Device enforcement)Recalled 2022-12-27class ii

MEDLINE INDUSTRIES, LP - Northfield: (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 Ster

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.

Details from the source

Reason for recall: The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization. Distribution: US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution. Quantity: 1,689 trays Lot/code info: (1) UDI/DI (01) 40193489230339; Lot numbers 21DLA284, exp. 10/31/2023; 21BLA250, exp. 2/28/2023; 20JLA617, exp. exp. 2/28./2023; 20ILA666, exp. 2/28/2023; 20ILA518, exp. 2/28/2023; 20ILA217, exp. 2/28/2023; and 20ILA054, exp. 11/30/2022. (2) UDI/DI (01) 40193489956895; Lot numbers 21HLA016, exp. 12/31/2023; 21ILA354, exp. 12/31/2023; 21JLA196, exp. 12/31/2023; 21KLA245, exp. 1/31/2024; 21LLA141, exp. 1/31/2024; 22ALA377, exp. 1/31/2024; 22CLB011, exp. 12/31/2023; 22ELA046exp. 6/30/2024; and 22FLA125, exp. 1/31/2024.

UPC codes

40193489230339, 40193489956895

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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