FDAClass IIDecember 20, 2023

PVP Solution Sing Strl recall: Sterility Concern

PVP SOLUTION SING STRL, REF DYNDA1858

Why was PVP Solution Sing Strl recalled?

The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.

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 40889942539858 (case), 10889942539857 (each), Lot numbers: 2023032090, 2023020990, 2022103190, 2022091690, 2022070190, 2022052090, 2022042290, 2022033190, 2021102290, 2021092190

Product
PVP SOLUTION SING STRL, REF DYNDA1858
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
1950 units
Distribution
US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.
Recall date
December 20, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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