Z-2166-2019 Class II Terminated
FDA device recall Z-2166-2019 was initiated by Centurion Medical Products Corporation on July 1, 2019 and is designated Class II. Reason for recall: Potential for sterile packaging to be compromised The recall status is terminated (terminated June 26, 2020). Affected quantity: 1224 each.
Recall Details
- Product Type
- Devices
- Report Date
- August 14, 2019
- Initiation Date
- July 1, 2019
- Termination Date
- June 26, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1224 each
Product Description
LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.
Reason for Recall
Potential for sterile packaging to be compromised
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.
Code Information
Lot # 2019031190 Exp: 06/30/2020