Device product
LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.
Z-2166-2019
Product summary
- Event
- Event 83329
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1224 each
- Official record key
device-enforcement:Z-2166-2019
Official wording
Reason: Potential for sterile packaging to be compromised
Code information: Lot # 2019031190 Exp: 06/30/2020
Distribution pattern: US Nationwide distribution in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, WI.
Derived failure modes
-
Sterility assurance
sterile packaging to be compromised