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U.S. Department of Health and Human Services

Class 2 Device Recall eSwallow MultiProgram Dysphagia Therapy Test unit

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  Class 2 Device Recall eSwallow MultiProgram Dysphagia Therapy Test unit see related information
Date Initiated by Firm June 22, 2011
Date Posted July 25, 2011
Recall Status1 Terminated 3 on July 03, 2012
Recall Number Z-2880-2011
Recall Event ID 59178
Product Classification Stimulator, muscle, powered - Product Code IPF
Product eSwallow Multi-Program Dysphagia Therapy Test unit

Intended Use: Powered Muscle Stimulator for treatment of dysphagia.
Code Information all lot numbers
Recalling Firm/
Manufacturer		 eSwallow USA LLC
106 Hidden Drive
Scottsboro AL 35769-9322
For Additional Information Contact William R. Ingram
256-571-0443
Manufacturer Reason
for Recall		 It was discovered that the firm was distributing medical devices without FDA approval.
FDA Determined
Cause 2		 Other
Action eSwallow USA LLC sent an URGENT MEDICAL DEVICE RECALL letter dated June 22 2011, via US mail and email notification to each distributors. The letter identified the product, the problem, and the action to be taken. Distributors were instructed to immediately examine inventory, quarantine all product subject to recall, and identify customers that received these products and notify them at once of the recall. The letter advised distributors to forward a copy of the recall notification letter to their customers. The letter states that the distributors are to return all inventories to the eSwallow Corporate Office eSWALLOWusa, 106 Hidden Drive, Scottsboro, Al 35769. The recall should be carried out to the customer/user level. Customers are instructed to complete and return the attached Response Form as soon as possible. If you have any questions, call (256) 571-0443.
Quantity in Commerce 123 units
Distribution Nationwide (USA) Distribution - including states of AL, AZ, CA, GA, FL, LA, MS, and VA.
Total Product Life Cycle TPLC Device Report
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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