Z-1678-2015Class II

KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent...

Name: Z-1678-2015 KimVent Turbo-Cleaning Closed Suction System for Adults, 10 F T-Piece (Product Code 227105); KimVent...
Creator: Halyard Health, Inc
Published: 2015-04-14
License: https://open.fda.gov/license/

Halyard Health / initiated 2015-04-14 / Terminated / root cause: design

FDA source

Halyard Health, Inc began a recall of 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... on 2015-04-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1678-2015
Classification: Class II
Status: Terminated
Initiated: 2015-04-14
Posted: 2015-05-26
Terminated: 2015-07-07
Recalling firm: Halyard Health
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).
Product code: BSY Catheters, Suction, Tracheobronchial
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: Halyard Health Regulatory Affairs sent an Urgent Voluntary Product Recall letter dated April 16, 2015, to all affected consignees. Consignees were instructed to quarantine and discontinue use of the recalled product. Specific return instructions were provided in the Notice. The consignees were also requested to provide a response to to the recall notification. Wholesalers were instructed to follow their internal recall procedures to identify and address affected products. Consignees with questions were instructed to call Halyard Health Regulatory Affairs at 470-448-5700.
Quantity in commerce: 11 cases each containing 20 individual endotracheal tubes
Distribution: Nationwide Distribution including CA, MA, MI, NC, TX, VA , and WA.
Product codes and lots: M5019T311, M4335T317, M5034T317, M5040T311 & M5005T303

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1678-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1678-2015	Class II	Terminated	Voluntary: Firm initiated	2015-06-03	2015-05-26

Product code BSY

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)