CLASS II Device recall · Reported 9 Sep 2015 · FDA Enforcement Report
KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product recalled
Halyard Health is recalling KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (, distributed nationwide in the US. The recall was initiated on 29 Jul 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2508-2015
- FDA event ID
- 71966
- Recalling firm
- Halyard Health, Alpharetta, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jul 2015
- FDA classified
- 31 Aug 2015
- Reported
- 9 Sep 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Heart & Vascular Devices
Timeline
| 29 Jul 2015 | Recall initiated by company | |
| 31 Aug 2015 | Classified by FDA | +33 days |
| 9 Sep 2015 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 22108); KimVent* Closed Suction System for Adults, 14 F, DSE, MDI (Product Code 221038) 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.
Where it was distributed
Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Product Code 22108 - M5082T626, M5089T625; Product Code 221038 - M5089T606, M5089T631
Where was it sold?
Worldwide Distribution - US (nationwide and Puerto Rico and Internationally to Canada
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
31 other products · FDA event 71966This product is part of a recall event; the main page for the event is NovaPlus Trach Care* Closed Suction System for Adults recalled.
More recalls from Halyard Health
All 57| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE) recalled | Halyard Health | Other | Nationwide |
| Device | CLASS II | Halyard Closed Suction System for Adults recalled by Halyard Health | Halyard Health | Other | Nationwide |
| Device | CLASS II | Halyard Closed Suction System for Adults, Turbo recalled | Halyard Health | Other | Nationwide |
| Device | CLASS II | Cortrak* 2 Nasogastric/Nasointestinal recalled by Halyard Health | Halyard Health | Other | Nationwide |
| Device | CLASS II | Halyard Closed Suction System for Adults, 14 F, T-Piece recalled | Halyard Health | Packaging Defects | 38 states |
Other Heart & Vascular Devices recalls
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|---|---|---|---|---|---|
| Device | CLASS II | Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled | Atrium Medical | Potency & Assay | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes: *Bardex¿ I.C recalled | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Products that contain the Pericare Wipes recalled by C.R. Bard | C.R. Bard | Other | Nationwide |
| Device | CLASS II | Getinge PVC Thoracic Catheter, Firm PVC Straight recalled | Atrium Medical | Potency & Assay | Nationwide |