FDAClass IIDecember 20, 2023

Sterile Sterile Prep Stick recall: Sterility Concern

STERILE STERILE PREP STICK, REF DYNDA1134

Why was Sterile Sterile Prep Stick 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 40888277098023 (case), 10888277098022 (each), Lot numbers: 2023082190

Product
STERILE STERILE PREP STICK, REF DYNDA1134
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
240 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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