Recall Z-1044-2016— ConvaTec, Inc
Class II · Terminated
Class II FDA medical device recall by ConvaTec, Inc, initiated 2015-11-11, terminated 2016-07-18. It names one FDA 510(k) clearance: K801867. Product: Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.. Reason: The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer..
- Recalling firm
- ConvaTec, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-11-11
- Terminated
- 2016-07-18
- Firm location
- Greensboro, NC, 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
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.
Reason for recall
The Nebulizer mask malfunctions in that there is reduced or no aerosol output. The malfunction occurs from the reduction in the diameter of a component part inside the nebulizer.
Data sourced from openFDA. This site is unofficial and independent of the FDA.