FDA-Device2023-03-01Class II
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;
MEDLINE INDUSTRIES, LP - Northfield
Hazard
The convenience trays had improper placement of some of the components that were in the nonsterile portion of the tray, thus, not receiving sterilization.
Sold states
US Nationwide distribution in the states of AR, CO, and GA. There was no foreign/military/government distribution.
Affected count
4,360 trays
Manufactured in
3 Lakes Dr, N/A, Northfield, IL, United States
Products
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;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1161-2023Don't want to check this manually?
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