ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.
Reported: October 10, 2012 Initiated: April 23, 2012 #D-004-2013
Product Description
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.
Reason for Recall
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Details
- Recalling Firm
- Carefusion 213, Llc
- Units Affected
- 576 Cartons
- Distribution
- IL, MO, and NJ
- Location
- El Paso, TX
Frequently Asked Questions
What product was recalled? ▼
ChloraPrep One-Step (2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol) Patient Preoperative Skin Preparation, 3mL Applicators, 25 Applicators per Carton, Single Use, Latex Free, Applicator is STERILE if package is intact, NDC 54365-400-01.. Recalled by Carefusion 213, Llc. Units affected: 576 Cartons.
Why was this product recalled? ▼
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 10, 2012. Severity: Moderate. Recall number: D-004-2013.
Related Recalls
NHTSA Critical
LEXUS 2025: POWER TRAIN:AUTOMATIC TRANSMISSION
LEXUS · 2026-02-18
NHTSA Critical
CADILLAC,CHEVROLET,GMC 2022: POWER TRAIN:AUTOMATIC TRANSMISSION:CONTROL MODULE:SOFTWARE
CADILLAC,CHEVROLET,GMC · 2026-02-13
NHTSA Critical
CHEVROLET,GMC 2020-2022: POWER TRAIN:AUTOMATIC TRANSMISSION:CONTROL MODULE:SOFTWARE
CHEVROLET,GMC · 2026-02-12
NHTSA Critical
CADILLAC 2024: BACK OVER PREVENTION:SOFTWARE
CADILLAC · 2026-02-12
NHTSA Critical
NISSAN 2024-2025: FUEL SYSTEM, GASOLINE:FUEL INJECTION SYSTEM:THROTTLEBODY/MANIFOLD
NISSAN · 2026-02-12