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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Event Detail

Event ID 65098
Product Type Devices
Status Ongoing
Recalling Firm American Optisurgical Inc
City Lake Forest
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-04-30
Initial Firm Notification of
Consignee or Public
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray. Lot Numbers 07912-06 12912-04 Class II 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. 63 individual applicators Z-1505-2013