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Terminated

LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.

FDA Recall Z-2166-2019 · Posted None

Recalling FirmCenturion Medical Products Corporation
Recall StatusTerminated
Product CodeOXQ
Date Initiated2019-07-01
Date Terminated2020-06-26
Product Quantity1224 each

Reason for Recall

Potential for sterile packaging to be compromised

Firm Action

1) Please identify all inventory that you have within your possession and segregate the recalled product. 2) Please complete the enclosed accountability record, whether or not you have product, and fax or email at your earliest convenience to the attention of Lisa Carpenter as directed. Upon receipt of this record, your response will be documented, and a Centurion Representative will contact you regarding retrieval of the product from your facility, if required. 3) Please forward a copy of this notice to any facilities to whom this product may have been further distributed. Please contact the number for any question (517) 546-5400 Ext.1122.

Root Cause

Employee error

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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