Z-1161-2023 Class II Ongoing
FDA device recall Z-1161-2023 was initiated by MEDLINE INDUSTRIES, LP - Northfield on Dec 27, 2022 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 4,360 trays.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 1, 2023
- Initiation Date
- Dec 27, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,360 trays
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.
Distribution Pattern
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1161-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026