Device product
Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing Ethicon Biopatch Protective Disk with CHG, Disk with Chlorhexidine Gluconate (CHG), DRSG Biopatch 1IN NS, VPN: 10150;
Z-1161-2023
Product summary
- Event
- Event 91457
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 4,360 trays
- Official record key
device-enforcement:Z-1161-2023
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: UDI/DI (01) 40888277986412; Lot numbers 22OBD978, exp. 1/31/2023; 22HBR887, exp. 12/31/2023; 22GBD420, exp. 12/31/2023; 22EBK277, exp. 12/31/2023; 22EBK012, exp. 9/30/2023; 22EBA934, exp. 1/31/2024; 22ABK594, exp. 4/30/2023; 21KBS545, exp. 6/30/2022; and 21JBL152, exp. 2/28/2023.
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.