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Recall Observatory FDA recall evidence

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

July 01, 2019

Class II

Product summary

Firm
Centurion Medical Products Corporation
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

    reason.sterility_assurance · v1.0.0

    sterile packaging to be compromised