Device product
(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.
Z-1162-2023
Product summary
- Event
- Event 91457
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 720 trays
- Official record key
device-enforcement:Z-1162-2023
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) 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.
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.