Retiro De Equipo (Recall) de Device Recall Shoulder Flex Massage Device

Recall

59829

Class 1

Z-0172-2012

2011-08-30

2011-11-10

Terminated

2014-03-06

The covered rotating mechanism can catch on user's clothing, jewelry (e.G. necklace), and hair. there have been reports of one death and a strangulation associated with using the device.

An Urgent Product Recall letter was sent via regular mail to customers. The letter identified the affected product and described the reason for the recall. Customers were asked to stop using Shoulderflex massagers immediately and to safely dispose of them in the trash. The device components should be disposed of separately so that the device cannot be reassembled and used. This means that the power supply should be separated from the massager unit, and the massage fingers should also be removed and disposed of separately. Customers are to complete and return the enclosed the postage-paid card to King International in order to confirm receipt of the recall letter. If additional information is needed regarding this recall, customers are to contact King International LLC at 503-524-7046 or visit their website at www.shoulderflex.com or via mail to PO Box 2384, Beaverton, Oregon 97075. On 8/25/2011 FDA published a health alert on the FDA website. On 8/31/2011 the firm issued a nationwide press release.