LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.
Reported: August 14, 2019 Initiated: July 1, 2019 #Z-2166-2019
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
Details
- Recalling Firm
- Centurion Medical Products Corporation
- Units Affected
- 1224 each
- Distribution
- 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.
- Location
- Williamston, MI
Frequently Asked Questions
What product was recalled? ▼
LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.. Recalled by Centurion Medical Products Corporation. Units affected: 1224 each.
Why was this product recalled? ▼
Potential for sterile packaging to be compromised
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 14, 2019. Severity: Moderate. Recall number: Z-2166-2019.
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