Recall Z-0128-2014 ยท EWL Prosthesis, Laryngeal (Taub)
Helix Medical LLC
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
| Date | Nov 1, 2013 (initiated Oct 1, 2013) |
| Status | Terminated |
| Reason | InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATSV II Valve product cannot be used as intended without the product body. |
| Root cause | Packaging change control |
| Action | A phone script and a customer notification letter are provided. The recall was initiated on 10/1/13 and customers will be notified that InHealth Technologies, a division of Helix Medical, LLC has initiated a recall of the following 3 lots of the Blom-Singer Adjustable Tracheostoma Valve (BE8025H and BE8025H-R3): 1057760, 1057919 and 1059222. The phone script provides the problem identified and the actions to be taken. Customers are instructed to complete the Customer response form and return by email to belinda.jackson@helixmedical.com, fax to (805) 566-5381 or by mail to InHealth Technolog |
| Quantity | 47 units |
| Distribution | Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K821568 | BLOW-SINGER TRACHEOSTOMA VALVE Bivona Medical Technologies, Jul 26, 1982 |