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

Recalled November 29, 2017 · FDA recall Z-0119-2018 · Halyard Health

Hazard

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 Class II

Units

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

Sold at

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

Description

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.

Product

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

Manufacturer(s)

Halyard Health, Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →