ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, Ext...
FDA Recall #D-1674-2012 — Class II — November 8, 2011
Product Description
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
Reason for Recall
Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Recalling Firm
Carefusion 213, Llc — El Paso, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
67,775 Applicators
Distribution
Nationwide
Code Information
Product code 260415, Lot#: 48225
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated