PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: September 26, 2012 Initiated: November 8, 2011 #D-1674-2012

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.

Details

Recalling Firm
Carefusion 213, Llc
Units Affected
67,775 Applicators
Distribution
Nationwide
Location
El Paso, TX

Frequently Asked Questions

What product was recalled?
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. Recalled by Carefusion 213, Llc. Units affected: 67,775 Applicators.
Why was this product recalled?
Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Which agency issued this recall?
This recall was issued by the FDA Drug on September 26, 2012. Severity: Moderate. Recall number: D-1674-2012.