CLASS II Device recall · Reported 29 Nov 2017 · FDA Enforcement Report

Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak recalled

Halyard Health is recalling Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak, distributed in 38 states. The recall was initiated on 6 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Code 22106 with Lots AB6011U20, AB6123U07 AB6123U01, AB3207U04, AB6284U17; Product Code 221036 with Lot AB6263U11; Product Code 22108147 with Lots AB6011U15, AB6067U17, AB6256U13

Quantity recalled52,660 kits (2,633 cases) with 631,920 saline vials

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-0119-2018
FDA event ID: 78391
Recalling firm: Halyard Health, Alpharetta, GA
Classification: Class II
Status: Terminated
Recall initiated: 6 Oct 2017
FDA classified: 18 Nov 2017
Reported: 29 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

6 Oct 2017	Recall initiated by company
18 Nov 2017	Classified by FDA	+43 days
29 Nov 2017	Published in enforcement report	+11 days

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

Reason for recall

Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.

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

Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.

Where it was distributed

Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV

Alabama Arizona California Colorado Delaware Florida Georgia Hawaii Iowa Illinois Indiana Kansas Kentucky Louisiana Massachusetts Maryland Michigan Minnesota Missouri Mississippi

Questions about this recall

Is Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak recalled?

Yes. Halyard Health recalled Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak on 6 Oct 2017. The recall is Class II and its status is Terminated. Recall number Z-0119-2018.

Why was it recalled?

Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.

Which lots are affected?

Product Code 22106 with Lots AB6011U20, AB6123U07 AB6123U01, AB3207U04, AB6284U17; Product Code 221036 with Lot AB6263U11; Product Code 22108147 with Lots AB6011U15, AB6067U17, AB6256U13

Where was it sold?

Distributed domestically to AL, AZ, CA, CO, DE, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, PA, PR, RI, SC, SD, TN, TX, VA, WA, WV

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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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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