Device 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.
Z-1163-2023
Product summary
- Event
- Event 91457
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,689 trays
- Official record key
device-enforcement:Z-1163-2023
Official wording
Reason: The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
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.
Distribution pattern: US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution.
Derived failure modes
-
Unknown
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.