FDA-Device2015-06-03Class II
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).
Halyard Health, Inc
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.
Sold states
Nationwide Distribution including CA, MA, MI, NC, TX, VA , and WA.
Affected count
11 cases each containing 20 individual endotracheal tubes
Manufactured in
5405 Windward Pkwy, Alpharetta, GA, United States
Products
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).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1678-2015Don't want to check this manually?
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