FDAFDA · Food and drugs·Recall number Z-0122-2018
Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case.
Published November 29, 2017 · Recall initiated: October 6, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Halyard Health, Inc
- Distributor
- 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
- Lot
- Product Code 22012356 with Lot AB6032U10; Product Code 2208A055 with Lot AB6291U17
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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