CLASS I Device recall · Reported 31 Dec 2014 · FDA Enforcement Report

KimVent Microcuff Subglottic Suctioning, Endotracheal Tube recalled

Halyard Health is recalling KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, distributed nationwide in the US. The recall was initiated on 17 Nov 2014 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesProduct Code: 13222, Lot numbers: AA3213, AA3213V03, AA3227, AA3227V01, AA3239, AA3239V01, AA3245, AA3245V02, AA3249, AA3249V01, AA3249V03, AA3253V02, AA3269V01, AA3274, AA3274V01, AA3274V04, AA4038, AA4038V03, AA4038V04, AA4038V06, AA4062, AA4062V01, AA4062V03, AA4062V04, AA4083, AA4083V02, AA4097, AA4097V02, AA4097V04, AA4104V01, AA4104V02, AA4111, AA4111V01, AA4111V02, AA4113V01, AA4125V03, AA4134V01, AA4146V01, AA4146V04, AA4155V03, AA4167V01, AA4170V01, AA4174V01, AA4217V01 & AA4226V01.

Quantity recalled400 cases (10 tubes per case)

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-0867-2015
FDA event ID: 69910
Recalling firm: Halyard Health, Roswell, GA
Classification: Class I
Status: Terminated
Recall initiated: 17 Nov 2014
FDA classified: 24 Dec 2014
Reported: 31 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

17 Nov 2014	Recall initiated by company
24 Dec 2014	Classified by FDA	+37 days
31 Dec 2014	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The cuff inflation line may detach from the endotracheal tube during use.

Product as listed by the FDA

KimVent Microcuff Subglottic Suctioning, Endotracheal Tube, 8.0 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.

Where it was distributed

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.

Nationwide Alabama Arkansas Arizona California Connecticut Florida Georgia Indiana Kansas Kentucky Massachusetts Maine Michigan Missouri Mississippi Montana North Dakota New Hampshire Ohio Oklahoma

Questions about this recall

Why was it recalled?

The cuff inflation line may detach from the endotracheal tube during use.

Which lots are affected?

Product Code: 13222, Lot numbers: AA3213, AA3213V03, AA3227, AA3227V01, AA3239, AA3239V01, AA3245, AA3245V02, AA3249, AA3249V01, AA3249V03, AA3253V02, AA3269V01, AA3274, AA3274V01, AA3274V04, AA4038, AA4038V03, AA4038V04, AA4038V06, AA4062, AA4062V01, AA4062V03, AA4062V04, AA4083, AA4083V02, AA4097, AA4097V02, AA4097V04, AA4104V01, AA4104V02, AA4111, AA4111V01, AA4111V02, AA4113V01, AA4125V03, AA4134V01, AA4146V01, AA4146V04, AA4155V03, AA4167V01, AA4170V01, AA4174V01, AA4217V01 & AA4226V01.

Where was it sold?

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 I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

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

4 other products · FDA event 69910

This product is part of a recall event; the main page for the event is KimVent Microcuff Subglottic Suctioning, Endotracheal Tube recalled.

Reported	Class	Recall	Company	Reason	Where
31 Dec 2014	CLASS I	KimVent Microcuff Subglottic Suctioning, Endotracheal Tube recalled	Halyard Health	Other	Nationwide
31 Dec 2014	CLASS I	KimVent Microcuff Subglottic Suctioning, Endotracheal Tube recalled	Halyard Health	Other	Nationwide
31 Dec 2014	CLASS I	KimVent Microcuff Subglottic Suctioning, Endotracheal Tube recalled	Halyard Health	Other	Nationwide
31 Dec 2014	CLASS I	KimVent Microcuff Subglottic Suctioning, Endotracheal Tube recalled	Halyard Health	Other	Nationwide

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