CLASS II Device recall · Reported 11 Mar 2015 · FDA Enforcement Report

KimVent Closed Suction System for Adults, Double Swivel Elbow recalled

Halyard Health is recalling KimVent Closed Suction System for Adults, Double Swivel Elbow, distributed in 11 states. The recall was initiated on 16 Jan 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code; 22103, Lot number: M4132T614

Quantity recalled5 cases (20 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-1221-2015
FDA event ID: 70397
Recalling firm: Halyard Health, Roswell, GA
Classification: Class II
Status: Terminated
Recall initiated: 16 Jan 2015
FDA classified: 27 Feb 2015
Reported: 11 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

16 Jan 2015	Recall initiated by company
27 Feb 2015	Classified by FDA	+42 days
11 Mar 2015	Published in enforcement report	+12 days

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

Reason for recall

Defect: A hole or crack was found which may cause air to leak.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

KimVent Closed Suction System for Adults, Double Swivel Elbow, 14 Fr. Sterile, Distributed by Kimberly Clark Global Systems, LLC.

Where it was distributed

CA, FL, IL, LA, MA, MK, MN, MS, NM, NY, OK and TX and Japan.

California Florida Illinois Louisiana Massachusetts Minnesota Mississippi New Mexico New York Oklahoma Texas

Questions about this recall

Why was it recalled?

Defect: A hole or crack was found which may cause air to leak.

Which lots are affected?

Product Code; 22103, Lot number: M4132T614

Where was it sold?

CA, FL, IL, LA, MA, MK, MN, MS, NM, NY, OK and TX and Japan.

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

2 other products · FDA event 70397

This product is part of a recall event; the main page for the event is KimVent Closed Suction System for Adults recalled by Halyard Health.

Reported	Class	Recall	Company	Reason	Where
11 Mar 2015	CLASS II	KimVent Closed Suction System for Adults recalled by Halyard Health	Halyard Health	Packaging Defects	11 states
11 Mar 2015	CLASS II	KimVent Wet Pak, Closed Suction System for Adults recalled	Halyard Health	Packaging Defects	11 states

More recalls from Halyard Health

All 57

Reported	Class	Recall	Company	Reason	Where
25 Apr 2018Device	CLASS II	Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE) recalled	Halyard Health	Other	Nationwide
25 Apr 2018Device	CLASS II	Halyard Closed Suction System for Adults recalled by Halyard Health	Halyard Health	Other	Nationwide
25 Apr 2018Device	CLASS II	Halyard Closed Suction System for Adults, Turbo recalled	Halyard Health	Other	Nationwide
11 Apr 2018Device	CLASS II	Cortrak* 2 Nasogastric/Nasointestinal recalled by Halyard Health	Halyard Health	Other	Nationwide
29 Nov 2017Device	CLASS II	Halyard Closed Suction System for Adults, 14 F, T-Piece recalled	Halyard Health	Packaging Defects	38 states

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