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Recall Observatory FDA recall evidence

Device product

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

Z-0128-2014

October 01, 2013

Class III

Product summary

Firm
Helix Medical LLC
Event
Event 66423
Status
Terminated
Classification
Class III
Quantity
47 units
Official record key
device-enforcement:Z-0128-2014

Official wording

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.

Code information: LOTS: 1057760, 1057919 and 1059222

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.