Z-0869-2015Class I

KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global...

Name: Z-0869-2015 KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global...
Creator: Halyard Health
Published: 2014-11-17
License: https://open.fda.gov/license/

Halyard Health / initiated 2014-11-17 / Terminated / root cause: manufacturing process

FDA source

Halyard Health began a recall of KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral... on 2014-11-17. FDA classified it as Class I and gives the reason as "The cuff inflation line may detach from the endotracheal tube during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0869-2015
Classification: Class I
Status: Terminated
Initiated: 2014-11-17
Posted: 2014-12-24
Terminated: 2015-08-18
Recalling firm: Halyard Health
Product: KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 9.0 mm, Distributed by Kimberly Clark Global Sales, LLC. Used for airway management by oral intubation of the trachea and for removal of secretions that accumulate in the subglottic space.
Product code: BTR Tube, Tracheal (W/Wo Connector)
Reason for recall: The cuff inflation line may detach from the endotracheal tube during use.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Halyard Health, sent an "URGENT: VOLUNTARY PRODUCT RECALL" letter dated November 17, 2014 via FedEx to its Consignees/customers. The letter describes the product, problem and actions to be taken. 'the customers were instructed to please evaluate your facilities for unused inventory of KimVent* Microcuff* Subglottic Suctioning Endotracheal Tubes, if present, quarantine and discontinue use; complete the attached Distributor Product Recall Response Form via fax to: 678-254-0391 within five (5) business days of receipt of this letter; if you are in possession of the affected product lots, a Halyard Health representative will provide a return authorization and instructions on shipping product to a specified distribution center, and; follow your internal product recall procedures to identify and address affected product. If you require further assistance, please call Halyard Health Regulatory Affairs at 770-587-7400.
Quantity in commerce: 80 cases (10 tubes per case)
Distribution: Worldwide Distribution: US (nationwide) AL, AR, AZ, CA, CT, FL, GA, IN, KS, KY, MA, ME, MI, MO, MS, MT, ND, NH, OH, OK, OR, PA, TN, UT, VA, and WV; and countries of: Australia, Canada, Europe (i.e., France, Germany, Great Britain, Ireland, Italy, Netherlands, Portugal, Sweden, & Switzerland), Hong Kong, New Zealand, and United Arab Emirates.
Product codes and lots: Product Code: 13224, Lot numbers: AA3274, AA3274V02, AA4062, AA4062V05, AA4092V02, AA4104V01, AA4111V03, AA4174V02 & AA4190V01.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0869-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0865-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-24
Z-0866-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-24
Z-0867-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-24
Z-0868-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-24
Z-0869-2015	Class I	Terminated	Voluntary: Firm initiated	2014-12-31	2014-12-24

Product code BTR

K131254Class IIKimvent Microcuff Subglottic Suctioning Endotracheal TubeKimberly-Clark Corp. / cleared 2013-08-20

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)