| Class 2 Device Recall FAST Procedure Kit | |
Date Initiated by Firm | April 30, 2013 |
Date Posted | June 06, 2013 |
Recall Status1 |
Terminated 3 on March 24, 2014 |
Recall Number | Z-1505-2013 |
Recall Event ID |
65098 |
Product Classification |
Skin prep tray (kit) - Product Code OJU
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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 CA 92630-8123
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For Additional Information Contact | 949-580-1266 |
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 | 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 |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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