FDA Device recall Z-1678-2015
KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105)
- FDA Device
- Class II
- terminated
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class II recall of KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105) by Halyard Health, citing 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 le….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1678-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-04-14 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Halyard Health |
| Distribution | US |
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.
Identifiers
| code_info | M5019T311, M4335T317, M5034T317, M5040T311 & M5005T303 |
|---|
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-1678-2015%22
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