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.

FDA recall notice · announced October 10, 2012 · Carefusion 213

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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.

Notes

Distribution: IL, MO, and NJ
Lot/code information: Lot 52894, Product Code: 260400
Quantity: 576 Cartons
Status: Terminated
Products in this recall event:
- 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 (D-004-2013)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.