Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2166-2019 — LVAD DRESSING SYSTEM W/BIOPATCHKit Code: DM700 - Product Usage: Kit is used for Left Ventricular Assist Device Dressing System for general patient population.

U.S. FDA — Device Enforcement · United States · 2019-07-01 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2166-2019
Date of alert
2019-07-01
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Centurion Medical Products Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
2019031190
Reported risk: Potential for sterile packaging to be compromised
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.