FDA Medical Device Recalls (openFDA)
Helix Medical LLC: Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
- Recall number
- Z-0128-2014
- Recalling firm
- Helix Medical LLC
- Product
- Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
- Status
- Terminated
- Initiated
- 2013-10-01
- Posted
- 2013-11-01
- Terminated
- 2014-01-21
- 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 Technologies, 1110 Mark Avenue, Carpinteria, CA 93013. Customers are also instructed to Contact UPS at 1-800-742-5877 and provide In Health Technologies UPS account no., 846718. UPS will come to your site, package the recalled product(s) and ship it to InHealth Technologies at InHealth Technologies expense. Customers are instructed to respond within 10 days.
- Quantity
- 47 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.
- Lot, serial or model codes
- LOTS: 1057760, 1057919 and 1059222
- 510(k) numbers
- K821568
- PMA numbers
- not on file
- Product code
- EWL
- Firm FEI
- 2025182
- Firm city
- Carpinteria
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28