Z-0125-2018 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
NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 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 2V22108147 with Lot AB6018U07