FDAFDA · Food and drugs·Recall number Z-1678-2015
KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, DSE (Product Code 2271603); KimVent Turbo-Cleaning Closed Suction System for Adults, 12 F, T-Piece (Product Code 227135).
Published June 3, 2015 · Recall initiated: April 14, 2015
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The internal blue flapper valve of certain KimVent Turbo-Cleaning Closed Suction System for Adults may have a potential defect. If present, the defect potentially allows air to leak out of the closed ventilator circuit.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Halyard Health, Inc
- Distributor
- Nationwide Distribution including CA, MA, MI, NC, TX, VA , and WA.
- Lot
- M5019T311, M4335T317, M5034T317, M5040T311 & M5005T303
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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