# FDA recall Z-3045-2018

> **Beaver Visitec** · Class II · device recall initiated 2018-07-19.

## Product

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.

## 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.

## Distribution

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.

## Key facts

- **Recall number:** Z-3045-2018
- **Recalling firm:** Beaver Visitec
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-19
- **Report date:** 2018-09-19
- **Termination date:** 2019-05-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waltham, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3045-2018

## Citation

> AI Analytics. FDA recall Z-3045-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/Z-3045-2018. Source: US FDA. Licensed CC0.

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