Recalls / Class II
Class IID-004-2013
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.
- Affected lot / code info
- Lot 52894, Product Code: 260400
Why it was recalled
Lack of Assurance of Sterility: Firm mistakenly released quarantined, non conforming material that failed sterility testing.
Recalling firm
- Firm
- Carefusion 213, Llc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1550 Northwestern Dr, N/A, El Paso, Texas 79912-8000
Distribution
- Quantity
- 576 Cartons
- Distribution pattern
- IL, MO, and NJ
Timeline
- Recall initiated
- 2012-04-23
- FDA classified
- 2012-10-03
- Posted by FDA
- 2012-10-10
- Terminated
- 2013-09-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-004-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.