Recall Z-1678-2015— Halyard Health, Inc
Class II · Terminated
Class II FDA medical device recall by Halyard Health, Inc, initiated 2015-04-14, terminated 2015-07-07. FDA's recall record names no specific 510(k) clearance for this event. Product: 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).. Reason: 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..
- Recalling firm
- Halyard Health, Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-14
- Terminated
- 2015-07-07
- Firm location
- Alpharetta, GA, United States
Product description
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).
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.