Reported Mar 9, 2016 · Terminated
Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses…
ConvaTec, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: ConvaTec, Inc · 7900 Triad Center Dr Ste 400 · Greensboro, NC · 27409-9076
Is this the product you have?
- 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.
- Lot codes and dates
591 of 591 codes
lot/batch numbers 13-2313-2413-2913-3013-3113-32977509777497777978709787197873978749788097988980309803198033980349804398048980589805998099981039833098338983809849198520985469855698570985719857898595986359868398694987219872298730987339873898777987799878298840988419884398844988539885698859988679886898869988709887198969
- Amount recalled
- 3,605,700 pieces
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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