PlainRecalls
FDA Devices Moderate Class II Ongoing

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;

Reported: March 1, 2023 Initiated: December 27, 2022 #Z-1161-2023

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.

Details

Units Affected
4,360 trays
Distribution
US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
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;. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 4,360 trays.
Why was this product recalled?
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 1, 2023. Severity: Moderate. Recall number: Z-1161-2023.