Recalls / Class II
Class IID-1674-2012
Product
ChloraPrep with Tint, HI-Lite Orange, 3 mL Applicator, Patient Preoperative Skin Preparation, External Use Only, Sterile, product code 260415, Carefusion, Leawood, KS 66211, USA
- Affected lot / code info
- Product code 260415, Lot#: 48225
Why it was recalled
Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Recalling firm
- Firm
- Carefusion 213, Llc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1550 Northwestern Dr, El Paso, Texas 79912-8000
Distribution
- Quantity
- 67,775 Applicators
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2011-11-08
- FDA classified
- 2012-09-17
- Posted by FDA
- 2012-09-26
- Terminated
- 2013-05-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1674-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.