Halyard Health, Inc: Medical Device Recall in 2017 - (Recall #: Z-0119-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: October 6, 2017

Date Posted: November 29, 2017

Recall Number: Z-0119-2018

Event ID: 78391

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.

Status: Terminated

Product Quantity: 52,660 kits (2,633 cases) with 631,920 saline vials

Code Information:

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

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated