PlainRecalls
FDA Devices Moderate Class II Ongoing

MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A

Reported: July 19, 2023 Initiated: May 18, 2023 #Z-2135-2023

Product Description

MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A

Reason for Recall

Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".

Details

Units Affected
60 units
Distribution
Worldwide distribution - US Nationwide and the country of Panama.
Location
Northfield, IL

Frequently Asked Questions

What product was recalled?
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A. Recalled by MEDLINE INDUSTRIES, LP - Northfield. Units affected: 60 units.
Why was this product recalled?
Affected product lots were mislabeled as "STERILE PVP SLN" when they should have been titled "NON-STERILE PVP SOLUTION, STERILE PACKAGING".
Which agency issued this recall?
This recall was issued by the FDA Devices on July 19, 2023. Severity: Moderate. Recall number: Z-2135-2023.