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.
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