FDAClass IIJanuary 29, 2025

Brand Name: IMed Products Product Name: Dressing Change recall: Sterility Concern

Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A…

Why was Brand Name: IMed Products Product Name: Dressing Change recalled?

Potential for hole in package compromising sterility of the medical kit.

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?

Model No IM46062, UDI-DI 10853155008769, Lot Number 600022

Product
Brand Name: IMed Products Product Name: Dressing Change Kit with ChloraPrep 3mL & HaloGUARD Model/Catalog Number: IM46062 Software Version: N/A…
Recalling firm
Trinity Sterile, Inc.
Quantity
1,980 units
Distribution
US Nationwide distribution in the states of MD, PA, TN and TX.
Recall date
January 29, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls