Z-1505-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 12, 2013
- Initiation Date
- April 30, 2013
- Termination Date
- March 24, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63 individual applicators
Product Description
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Reason for Recall
American Optisurgical, Inc initiated a recall of ChloraPrep Hi-Lite Orange 3mL Applicator, in response to a sub-recall letter from Medline Industries, Inc due to lack of sterility assurance caused by an incomplete seal on the individual unit packaging.
Distribution Pattern
Nationwide Distribution-USA (nationwide) including the states of AZ, CA, FL, GA, IL, KS, MA, MI, NC, NJ, OH, PA, TN, TX, VA, and WI.
Code Information
Lot Numbers 07912-06 12912-04