FDA-Device2017-11-29Class II
Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit, 20 kits per case.
Halyard Health, Inc
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.
Sold states
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
Affected count
52,660 kits (2,633 cases) with 631,920 saline vials
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit, 20 kits per case.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0124-2018Don't want to check this manually?
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