Z-2522-2015 Class II Terminated
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
- N/A
Product Description
KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Product Code 208); KimVent* Closed Suction System for Pediatrics, 10 F, Elbow (Product Code 210); KimVent* Closed Suction System for Neonates/Pediatrics, 10 F, Elbow (Product Code 2103); KimVent* Closed Suction Systems for Neonates/Pediatrics, 8 F, Elbow (Product Code 8313); KimVent* Closed Suction System for Neonates/Pediatrics, 8 F, Elbow (Product Code 20083) 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 206 - M5076T503, M5082T501, M5091T504; Product Code 208 - M5089T506, M5096T507, M5103T509; Product Code 210 - M5091T509; Product Code 2103 - M5082T401, M5089T401, M5138T402; Product Code 8313 - M5089T508; Product Code 20083 - M5082T403, M5082T404, M5089T402, M5103T401, M5166T402