Medline Sterile Oncology Port Access Tray, Item #DYNDC2239, 20 sterile kits per case, containing ...
FDA Recall #Z-1161-2023 — Class II — December 27, 2022
Product Description
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;
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.
Recalling Firm
MEDLINE INDUSTRIES, LP - Northfield — Northfield, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
4,360 trays
Distribution
US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution.
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.
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated