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

Recall Z-0261-2022 — Quantum 2000 Electrosurgical Generators Cooper Surgical Part Number: 909075

U.S. FDA — Device Enforcement · United States · 2021-09-29 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0261-2022
Date of alert
2021-09-29
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
CooperSurgical, Inc.
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
2015090019
Reported risk: Coagulate function may not operate with the use of the Hand Switch, failure of the device to coagulate tissue may lead to a prolonged procedure requiring medical intervention to control any intraoperative bleeding and complete the case.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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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.