FDAClass IISeptember 26, 2012

ChloraPrep with Tint recall: Sterility Concern

ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415…

Why was ChloraPrep with Tint recalled?

Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.

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?

Product code 260415, Lot#: 48225

Product
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415…
Recalling firm
Carefusion 213, Llc
Quantity
67,775 Applicators
Distribution
Nationwide
Recall date
September 26, 2012
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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