Z-1163-2023 Class II Ongoing
FDA device recall Z-1163-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Dec 27, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 1,689 trays.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 1, 2023
- Initiation Date
- Dec 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,689 trays
Product Description
(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.
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 Pattern
US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution.
Code Information
(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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1163-2023
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026