The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
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: US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution. Quantity: 720 trays Lot/code info: (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.
40889942055518, 40195327069286
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.