FDA recall Z-1161-2023

MEDLINE INDUSTRIES, LP - Northfield · Class II · 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;

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.

Key facts

Status
Ongoing
Initiation date
2022-12-27
Report date
2023-03-01
Voluntary/Mandated
Voluntary: Firm initiated
Location
Northfield, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1161-2023