Recalls / Class II
Class IID-1442-2014
Product
ChloraPrep With Tint, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), 26 mL APPLICATOR, Hi-Lite Orange. Rx Only. CareFusion, El Paso, TX 79912. NDC: 054365-400-13.
- Affected lot / code info
- Lot #: 71132, Expiry: 02/2017
Why it was recalled
Lack of Assurance of Sterility; Immediate product pouches may not be properly sealed.
Recalling firm
- Firm
- CareFusion 213, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1550 Northwestern Drive, N/A, El Paso, Texas 79912-8000
Distribution
- Quantity
- 23,000 Applicators
- Distribution pattern
- Nationwide in U.S.
Timeline
- Recall initiated
- 2013-06-13
- FDA classified
- 2014-07-17
- Posted by FDA
- 2014-07-23
- Terminated
- 2015-04-22
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1442-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.