Recall Z-2880-2011 ยท IPF Stimulator, Muscle, Powered
eSwallow USA LLC
eSwallow Multi-Program Dysphagia Therapy Test unit Intended Use: Powered Muscle Stimulator for treatment of dysphagia.
| Date | Jul 25, 2011 (initiated Jun 22, 2011) |
| Status | Terminated |
| Reason | It was discovered that the firm was distributing medical devices without FDA approval. |
| Root cause | 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 eSwall |
| Quantity | 123 units |
| Distribution | Nationwide (USA) Distribution - including states of AL, AZ, CA, GA, FL, LA, MS, and VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.