Z-2492-2015 Class II Terminated
FDA device recall Z-2492-2015 was initiated by Halyard Health, Inc on July 29, 2015 and is designated Class II. Reason for recall: The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position. The recall status is terminated (terminated January 12, 2016). Affected quantity: 19,250 cases.
Recall Details
- Product Type
- Devices
- Report Date
- September 9, 2015
- Initiation Date
- July 29, 2015
- Termination Date
- January 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19,250 cases
Product Description
KimVent* Closed Suction System for Adults, 12 F, T-Piece (Product Code 2155); KimVent* Closed Suction System for Adults, 14 F, T-Piece (Product Code 2205, 8169, 8248, 22015, 22025, 220125, 220135) A tracheobronchial suction catheter is a device that is attached to a port of the airway circuit for use as needed to aspirate liquids or semisolids from a patient's upper airway.
Reason for Recall
The thumb valve of some KIMVENT Closed Suction Systems remained partially open after suctioning was completed, even though the valve appeared to be closed or in the "LOCKED" position.
Distribution Pattern
Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
Code Information
Product Code 2155 - M5166T402, M5166T622, M5166T631; Product Code 2205 - M5079T606, M5086T603, M5089T612, M5089T632, M5110T611, M5110T626, M5166T642; Product Code 8169 - M5103T608; Product Code 8248 - M5082T632; Product Code 22015 - M5082T603, M5089T609, M5096T607; Product Code 22025 - M5082T627, M5096T603; Product Code 220125 M5082T617, M5096T608; Product Code 220135 - M5054T619, M5079T604, M5082T620, M5089T614, M5096T622