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

Recall Z-3045-2018 — Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000 Product Usage: The indications and intended use of the High Temp cautery are for coagulating tissue or arresting bleeding from small vessels by heat conducted through the wire tip. Indications include opht

U.S. FDA — Device Enforcement · United States · 2018-07-19 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3045-2018
Date of alert
2018-07-19
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Beaver Visitec
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
30886158010297
Reported risk: A small number of devices in this lot may have a melted cap and a hole formed through the packaging. The risk is potentially the product will no longer be sterile for use and may cause harm to a patient.
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.

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.