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

MEDLINE INDUSTRIES, LP - Northfield: (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

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: 720 trays Lot/code info: (1) UDI/DI (01) 40889942055518; Lot numbers 21KBE911, exp. 3/31/2023; 21JBU806, exp. 3/31/2023; 21IBW034, exp. 3/31/2023; 21HBM415, exp. 3/31/2023; 21GBH194, exp. 3/31/2023; 21CBY712, exp. 3/31/2023; 21BBS824, exp. 3/31/2023; 21BBS043, exp. 3/31/2023; 20XBC895, exp. 12/31/2022; 20WBB357, exp. 8/31/2022; 20KBD323, exp. 9/30/2022; and 20JBT517, exp. 12/31/2021. (2) UDI/DI (01) 40195327069286; Lot number 22CBJ633, exp. 12/31/2022.

UPC codes

40889942055518, 40195327069286

Source

Official record: FDA (Device enforcement)

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

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