Status
Terminated
Drug Enforcement D-1674-2012
Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
Classification
Class II
Report Date
September 26, 2012
Termination Date
May 23, 2013
Product Information
- Product description
- 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
- Product quantity
- 67,775 Applicators
- Reason for recall
- Lack of Assurance of Sterility: A customer complaint reported some units had incomplete seals (open seals) on the Individual unit packaging.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- CareFusion 213, LLC
- Address
-
1550 Northwestern Dr
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1674-2012
- Event ID
- 62971
- Recall initiation date
- November 8, 2011
- Center classification date
- September 17, 2012
- Code info
- Product code 260415, Lot#: 48225
- More code info
- —