Z-0128-2014Class III

Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3

Name: Z-0128-2014 Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
Creator: Helix Medical LLC
Published: 2013-10-01
License: https://open.fda.gov/license/

Freudenberg Medical, LLC / initiated 2013-10-01 / Terminated / root cause: packaging

FDA source

Helix Medical LLC began a recall of Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3 on 2013-10-01. FDA classified it as Class III and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0128-2014
Classification: Class III
Status: Terminated
Initiated: 2013-10-01
Posted: 2013-11-01
Terminated: 2014-01-21
Recalling firm: Freudenberg Medical, LLC
Product: Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
Product code: EWL Prosthesis, Laryngeal (Taub)
Reason for recall: 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 tag: packaging
FDA 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 [email protected], 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 in commerce: 47 units
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.
Product codes and lots: LOTS: 1057760, 1057919 and 1059222

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0128-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0128-2014	Class III	Terminated	Voluntary: Firm initiated	2013-11-13	2013-11-01

Product code EWL

K821568Class IIBlow-Singer Tracheostoma ValveBivona Medical Technologies / cleared 1982-07-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)