Status
Terminated
Drug Enforcement D-004-2013
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Classification
Class II
Report Date
October 10, 2012
Termination Date
September 11, 2013
Product Information
- 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.
- Product quantity
- 576 Cartons
- Reason for recall
- Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- IL, MO, and NJ
Location & Firm
- Recalling firm
- CareFusion 213, LLC
- Address
-
1550 Northwestern Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-004-2013
- Event ID
- 62900
- Recall initiation date
- April 23, 2012
- Center classification date
- October 3, 2012
- Code info
- Lot 52894, Product Code: 260400
- More code info
- —