Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

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 ophthalmic, general and plastic surgery.

FDA Recall Z-3045-2018 · Posted None

Recalling FirmBeaver Visitec
Recall StatusTerminated
Product CodeHQP
Date Initiated2018-07-19
Date Terminated2019-05-23
Product Quantity800 units

Reason for Recall

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.

Firm Action

Urgent Medical Device Recall notification letters dated 7/19/18 were distributed to customers. The letters instructed customers to perform the following actions: 1. Identify the product. 2. Immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 3. Consider all potential users of this product in your wholesale and/or user level supply chain. Your assistance is appreciated and necessary to prevent patient harm. 4. Follow the attached Destruction Instructions to disable the wire tip to safely destroy this product to prevent activation or future use of this product. 5. Complete and return the enclosed response form as soon as possible. Please provide objective evidence of the product destruction and we will credit your account. Customers were also contacted via phone beginning 8/1/18

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - US Nationwide in the states of: CA, DC, FL, IA, ID, IL, MA, MI, MN, NY, OK, PA, TN, TX, UT, and WA and the countries of Australia, France, Netherlands, Spain, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

↑