MEDLINE INDUSTRIES, LP - Northfield: Medical Device Recall in 2023 - (Recall #: Z-2135-2023)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2023.
Data Source: FDA.
Product Description:
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
Product Classification:
Class II
Date Initiated: May 18, 2023
Date Posted: July 19, 2023
Recall Number: Z-2135-2023
Event ID: 92486
Reason for Recall:
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Status: Ongoing
Product Quantity: 60 units
Code Information:
UDI/DI (EA) (01)10193489799477, UDI/DI (01)40193489799478; Lot Numbers: 23CBS268
Distribution Pattern:
Worldwide distribution - US Nationwide and the country of Panama.
Voluntary or Mandated:
Voluntary: Firm initiated