Z-0117-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 29, 2017
- Initiation Date
- October 6, 2017
- Termination Date
- September 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 52,660 kits (2,633 cases) with 631,920 saline vials
Product Description
Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.
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.
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
Code Information
Product Code 2216 with Lot AB6032U03; Product Code 22056 with Lot AB6032U12; Product Code 220569 with Lot AB6207U11