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Terminated

Life Force Chamber Product Usage:The product is intended for restful contemplation and spirituality.

FDA Recall Z-2625-2014 · Posted 2014-09-11

Recalling FirmLife Force of Tampa, LLC
Recall StatusTerminated
Product CodeLGM
Date Initiated2014-06-27
Date Terminated2015-07-30
Product Quantity10

Reason for Recall

The Life Force chamber is marketed and promoted as a medical device, intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or is intended to affect the structure or function of the body. Life Force of Tampa does not have an approved application for premarket approval in effect, or an approved application for an investigat

Firm Action

Life Force of Tampa LLC sent an URGENT: MEDICAL DEVICE RECALL letter dated June 27, 2014 to all affected customers. The letter instructed the customers to: 1) Immediately remove and discard all copies of the labeling material. 2) Remove all electronic copies of the materials from any publicly accessible locations (e.g. website). 3) Complete and return the Acknowledgment form to Life Force of Tampa. For questions or concerns contact Douglas G. Cornell at (813) 961-4655.

Root Cause

Labeling False and Misleading

Distribution Pattern

Nationwide Distribution in the states of AZ, FL, MD, NV, OK, PA, and TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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