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

FDA device recall Z-0128-2014 · posted 2013-11-01 · Terminated

Recall details

Recalling firm

Helix Medical LLC

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.

Action taken

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.

Root cause

Packaging change control

Status

Terminated

Product code

EWL

Quantity affected

47 units

Distribution

Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.

Date initiated

2013-10-01

Date posted

2013-11-01

Date terminated

2014-01-21

Location

Carpinteria, CA

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