FDAClass IIApril 22, 2020

ChloraPrep With Tint recall: Sterility Concern

ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile…

Why was ChloraPrep With Tint recalled?

A nonsterile bulk product designated for further processing in a tray was inadvertently shipped to a customer.

What should I do if I have this product?

Review the official FDA enforcement record for current 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?

Merit lot number J559821

Product
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Patient Preoperative Skin Preparation, Non-sterile…
Recalling firm
Merit Medical Systems, Inc.
Quantity
6 units
Distribution
US Nationwide distribution in the state of IL. There was no other distribution.
Recall date
April 22, 2020
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls