FDA Device recall Z-2522-2015
KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206)
- FDA Device
- Class II
- terminated
- Published 2015-09-09
On 2015-09-09 the FDA classified a Class II recall of KimVent* Closed Suction System for Neonates/Pediatrics, 6 F, Elbow (Product Code 206) by Halyard Health, citing 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" posit….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2522-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-07-29 |
| Published | 2015-09-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Halyard Health |
| Distribution | US |
Product
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
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.
Identifiers
| code_info | Product Code 206 - M5076T503, M5082T501, M5091T504; Product Code 208 - M5089T506, M5096T507, M5103T509; Product Code 21…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2522-2015%22
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