Z-1558-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- November 14, 2019
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
FreeStyle Precision H Blood Glucose and Ketone Monitoring System, UDI: 00093815711810
Reason for Recall
Instructions sent in a letter or in instructions for use for disinfecting blood glucose and/or ketone meters were distributed but not cleared by the U.S. FDA, and devices were not cleared for multiple-patient use. Instructions could lead to inappropriate meter disinfection or improper handling of contaminated meters, which may cause infection or exacerbation of an existing infection.
Distribution Pattern
U.S.: KY, NY, TN, MA, IL, SC, VT, FL, CA, NC, MS, NJ, TX, AL, GA, OK, CT, PA, NE, ND, MT, MO, DC, ME, LA, KS, ID, OH, MN, NM, VA, IN
Code Information
All lots.