Recall Z-0128-2014— Helix Medical LLC
Class III · Terminated
Class III FDA medical device recall by Helix Medical LLC, initiated 2013-10-01, terminated 2014-01-21. It names one FDA 510(k) clearance: K821568. Product: Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3. 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..
- Recalling firm
- Helix Medical LLC
- Classification
- Class III
- Status
- Terminated
- Initiated
- 2013-10-01
- Terminated
- 2014-01-21
- Firm location
- Carpinteria, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.