(1) Medline Sterile Maximum Barrier Pack-LF, Item DYNJ0248546C, 6 kits per case, contains BD Chlo...
FDA Recall #Z-1162-2023 — Class II — December 27, 2022
Product Description
(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.
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.
Recalling Firm
MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
720 trays
Distribution
US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution.
Code Information
(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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated