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U.S. Department of Health and Human Services

Class 2 Device Recall FAST Procedure Kit

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 Class 2 Recall
FAST Procedure Kit
see related information
Date Posted June 06, 2013
Recall Status1 Terminated on March 24, 2014
Recall Number Z-1505-2013
Recall Event ID 65098
Product Classification Skin Prep Tray (Kit) - Product Code OJU
Product FAST Procedure Kit. Intended for use as a Minor Surgical Procedures Tray.
Code Information Lot Numbers 07912-06 12912-04
Recalling Firm/
Manufacturer
American Optisurgical Inc
26902 Vista Ter
Lake Forest, California 92630-8123
Manufacturer 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.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action American Optisurgical Inc. sent an "URGENT: VOLUNTARY MEDICAL DEVICE RECALL AND PRODUCT EXCHANGE" letter dated May 17, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the firm at 949-580-1266 for questions regarding this notice.
Quantity in Commerce 63 individual applicators
Distribution 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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