Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0128-2014 — Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3

U.S. FDA — Device Enforcement · United States · 2013-10-01 · Class III

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0128-2014
Date of alert
2013-10-01
Country / jurisdiction
United States
Risk level
Class III
Risk type
recall
Brand
Helix Medical LLC
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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