PLEASE NOTE:  AS PER HEALTH CANADA

November 22, 2010

As a valued member, iSTOP would like to keep you informed about safety issues regarding the treatment of Chronic Pain.  This is to notify you that the Piezo-DX Quartz Stimulator device is currently being recalled from the Canadian market.  This particular medical device has been sold in Canada since 2002.

This medical device is now being recalled by Health Canada because the manufacturer of the Piezo-DX Quartz Stimulator (ITO Company Ltd.) does not have a current Medical Device License from Health Canada.

In accordance with section 64 of the Canadian Medical Device Regulations, if you own one or more Piezo-DX Quartz Stimulators, please discontinue all clinical and/or personal usage and distribution of this particular medical device.

If you have in the past purchased this medical device from iSTOP or other suppliers for resale distribution, please contact your customers regarding this recall as instructed above.

March 2008

Under the Medical Device Regulation, medical devices Classfied as I, II and III that are manufactured, imported or distributed must have the appropriate Medical Devices License.

The supplier must provide a label on the boxes to include: Name of Item of Content, Health Canada Medical Device License #, the address of the Manufacturer,  Packaged and Expiry Date and Batch/Lot #.

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Orders must be faxed or mailed to our office.  We cannot take orders via the telephone because we need the form with your signature.

PLEASE NOTE:

Regrettably we are no longer able to sell needles to non-Canadian practitioners.  These practitioners should please contact our office for possible suppliers or refer to the list of suppliers you received at your IMS course.

The suppliers I have listed for the USA are:

OMS Medical Supplies Inc

1950 Washington Street

Braintree

Massachusetts, 02184

http://rodp.ridne.net/node-50094.html

Lhasa Medical Inc

http://www.lhasaoms.com/contact.ccml?11

In Vancouver you can contact:

Hi Med Healthcare Products

Tel          604-323-1738 / 1768

Fax         604-263-1788

e-mail     himed@lynx.bc.ca

PLEASE NOTE:

iSTOP no longer sells medical supplies, publications are available only.  Should you require a supply of needles, please refer to the list of suppliers you received at your IMS course.