Z-0119-2018Class II

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

Name: Z-0119-2018 Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case
Creator: Halyard Health, Inc
Published: 2017-10-06
License: https://open.fda.gov/license/

Halyard Health / initiated 2017-10-06 / Terminated

FDA source

Halyard Health, Inc began a recall of Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case on 2017-10-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0119-2018
Classification: Class II
Status: Terminated
Initiated: 2017-10-06
Posted: 2017-11-18
Terminated: 2020-09-01
Recalling firm: Halyard Health
Product: Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
Product code: BSY Catheters, Suction, Tracheobronchial
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.
FDA root cause: Under Investigation by firm
Action: Customers were notified via FedEx on 10/06/2017. Instructions included to evaluate and quarantine any affected product in current inventory. For their direct distributors, instructions were to complete and return the response form and also coordinate the return of any affected product. If further distributed, those end users and customers were instructed to destroy any affected product.
Quantity in commerce: 52,660 kits (2,633 cases) with 631,920 saline vials
Distribution: 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
Product codes and lots: Product Code 22106 with Lots AB6011U20, AB6123U07 AB6123U01, AB3207U04, AB6284U17; Product Code 221036 with Lot AB6263U11; Product Code 22108147 with Lots AB6011U15, AB6067U17, AB6256U13

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0119-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0117-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-18
Z-0118-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-18
Z-0119-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-18
Z-0120-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-18
Z-0121-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-18
Z-0122-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-18
Z-0123-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-18
Z-0124-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-18
Z-0125-2018	Class II	Terminated	Voluntary: Firm initiated	2017-11-29	2017-11-18

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)