FDAClass IIJuly 19, 2023

Medline Non-sterile PVP Solution recall: Sterility Concern

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

Why was Medline Non-sterile PVP Solution recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI/DI (EA) (01)10193489799477, UDI/DI (01)40193489799478; Lot Numbers: 23CBS268

Product
MEDLINE NON-STERILE PVP SOLUTION, packaged in kits as follows: HYSTERO PACK, Model Number DYNJ61448A
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
60 units
Distribution
Worldwide distribution - US Nationwide and the country of Panama.
Recall date
July 19, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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