Class II
Terminated
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.
- Company
- Carefusion 213, Llc
- Recall Initiated
- April 23, 2012
- Posted
- October 10, 2012
- Recall Number
- D-004-2013
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 576 Cartons
- Firm Location
- El Paso, TX, United States
Reason for Recall
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Distribution
IL, MO, and NJ
Lot / Code Info
Lot 52894, Product Code: 260400
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