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U.S. Department of Health and Human Services

Enforcement Report - Week of June 12, 2013

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Product Detail

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

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 Letter
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.