| Date Initiated by Firm | May 07, 2012 |
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| Date Posted | June 18, 2012 |
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| Recall Status1 |
Terminated 3 on July 16, 2012 |
| Recall Number | Z-1819-2012 |
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| Recall Event ID |
61868 |
| Product Classification |
Vibrator, therapeutic - Product Code IRO
|
| Product | US-001 Rev A brochure is a two sided tri-fold printed marketing brochure describing the approved labeling indications for use, precautions and general operational information of the Exer-Rest device, Models AT3800 and AT4700.
Ever-Rest US Brochure US-001 Rev A. Brochure: "***AT acceleration THERAPEUTICS***At Non-Invasive Medical Solutions (NIMS) we pride ourselves on being at the forefront of developing drug free wellness solutions coupled with accredited peer-reviewed clinical research...***Whole Body Periodic Acceleration (WBPA) therapy has been demonstrated to naturally activate the release of beneficial mediators like Nitric Oxide (NO) throughout the vasculature.***Nitric Oxide [NO] supports the functioning of endothelial cells that line the arterial walls. NO signals vascular smooth muscle to relax, thereby increasing blood flow through arteries and veins. With age arterial production and availability of Nitric oxide declines.***NiMS 4400 Biscayne Blvd., Miami, FL 33137 P 305.575.4200 F 305357534201***info@nims-inc.com www.nims-inc.com***NIMS, Acceleration Therapeutics and Exer-Rest are registered trademarks of Non-Invasive Monitoring Systems, Inc.***US-001 Rev A***"
Printed marketing brochure |
|---|
| Code Information |
Brochure US-001 Rev A |
| FEI Number |
2431353
|
Recalling Firm/
Manufacturer |
Non-Invasive Monitoring Systems, Inc.
4400 Biscayne Boulevard
Miami FL 33137
|
| For Additional Information Contact | Emerance Gummels
305-575-4200 |
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Manufacturer Reason
for Recall | Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which contain unsubstantiated direct and indirect claims. |
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FDA Determined
Cause 2 | Labeling False and Misleading |
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| Action | NiMS sent an Urgent Promotional Material Recall letter dated May 29, 2012, to all affected customers. NIMS contacted the 18 facilities by phone starting on May 29, 2012 and sent the 73 end users letters dated May 29, 2012. NiMS instructed customers to immediately examine their inventory and quarantine any of the US-001 or USA-002 brochures. If customers further distributed brochures customers were instructed to notify their customers at once by including a copy of the recall notification letter. Customers were requested to destroy all Exer-Rest promotional materials.
For any questions customers were instructed to call 305-575-4204.
For questions regarding this recall call 305-575-4201. |
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| Quantity in Commerce | US-001 Rev A brochure: 3665 |
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| Distribution | Nationwide Distribution |
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| Total Product Life Cycle | TPLC Device Report |
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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.
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