MIDAS TOUCH Electrosurgical/102 mm (4 inch) Blade Electrodes, Disposable, Sterile Single Use Device, Part #30-0012 and #

FDA device recall Z-0182-2007 · posted 2006-11-15 · Terminated

Recall details

Recalling firm

Olsen Medical

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.

Action taken

The 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.

Root cause

Other

Status

Terminated

Product code

JOS

Quantity affected

81 cases/972 pieces

Distribution

Worldwide, including USA, Japan, and New Zealand.

Date initiated

2006-08-29

Date posted

2006-11-15

Date terminated

2011-07-26

Location

Louisville, KY

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