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U.S. Department of Health and Human Services

Class 3 Device Recall BlomSinger Adjustable Tracheostoma Valve II

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  Class 3 Device Recall BlomSinger Adjustable Tracheostoma Valve II see related information
Date Initiated by Firm October 01, 2013
Date Posted November 01, 2013
Recall Status1 Terminated 3 on January 21, 2014
Recall Number Z-0128-2014
Recall Event ID 66423
510(K)Number K821568  
Product Classification Prosthesis, laryngeal (taub) - Product Code EWL
Product Blom-Singer Adjustable Tracheostoma Valve II
Models: BE8025H and BE8025H-R3
Code Information LOTS: 1057760, 1057919 and 1059222
Recalling Firm/
Helix Medical LLC
1110 Mark Ave
Carpinteria CA 93013-2918
For Additional Information Contact Dr. Mark Ostwald
Manufacturer 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.
FDA Determined
Cause 2
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 in Commerce 47 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.
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.
510(K) Database 510(K)s with Product Code = EWL and Original Applicant = BIVONA MEDICAL TECHNOLOGIES