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U.S. Department of Health and Human Services

Class 2 Device Recall MIDAS TOUCH

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 Class 2 Device Recall MIDAS TOUCHsee related information
Date Initiated by FirmAugust 29, 2006
Date PostedNovember 15, 2006
Recall Status1 Terminated 3 on July 26, 2011
Recall NumberZ-0182-2007
Recall Event ID 36470
510(K)NumberK973234 
Product Classification electrosurgical electrodes - Product Code JOS
ProductMIDAS TOUCH Electrosurgical/102 mm (4 inch) Blade Electrodes, Disposable, Sterile Single Use Device, Part #30-0012 and #30-0002. The electrodes are individually packaged in Tyvek bags with 12 packages per case.
Code Information 4 inch Standard Electrodes - Model Number: 30-0002, Lot Numbers: 110201, 116228, 117331, 117985, 120959 and 000501; and 4 inch Modified Electrodes - Part Number: 30-0012, Lot Numbers: 110101, 113523, 113877, 114428, 114527, 115294, 115420, 119874, 120223, 120732 and 120883.
FEI Number 3000719969
Recalling Firm/
Manufacturer		 Olsen Medical
3001 W Kentucky St
Louisville KY 40211-1505
For Additional Information Contact
502-772-4280
Manufacturer Reason
for Recall		Testing conducted by the firm indicates that electrodes identified with certain part numbers may fall out from the electrosurgical pencil or handle presenting the potential for harm or injury to the patient and/or user.
FDA Determined
Cause 2		Other
ActionThe firm issued an ''Urgent: Device Recall'' notification to their customers via letter and E-mail on 8/29/2006 and 8/30/2006. The letter informs the customers of this problem and asks that the customers contact their sub-accounts and notify them of the problem if they have further distributed any of the suspect part numbers. The letter also asks that the distributor/customer(s) have the subaccounts discontinue use of the product; and return the held product to the distributor (who in turn, should return the product to Olsen Medical for reimbursement). The customers are asked to complete and fax back to the recalling firm, an attached Acknowledgement form documenting receipt of the recall notification by the customer/employee with name and date received. The firm also asked that the customer supply information regarding the amount of inventory /shipped on a checklist. The amounts received are broken down on the Checklist by Lot Number with the amount of product in inventory and the amount of product shipped. These amounts are reported by the responders by ''pieces and cases'' on hand at the time that the notice was received.
Quantity in Commerce81 cases/972 pieces
DistributionWorldwide, including USA, Japan, and New Zealand.
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = JOS
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