Home / Recalls / Beaver Visitec / Z-3045-2018

Z-3045-2018 Class II Terminated

Recalled by Beaver Visitec — Waltham, MA

Recall Details

Product Type
Devices
Report Date
September 19, 2018
Initiation Date
July 19, 2018
Termination Date
May 23, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
800 units

Product Description

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 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.

Code Information

Lot 6002809, UDI 8445000 30886158010297

Other recalls by Beaver Visitec

  • Z-1111-2019 Class II — Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized in C (March 12, 2019)
  • Z-1088-2019 Class III — Micro Knife 5.0mm 30¿, Part Number 0001522 The Beaver¿ Micro Knife 5.0mm 30 (February 19, 2019)
  • Z-1066-2019 Class II — BVI Visitec Soft Tip Cannula, 0.8MM .50 x 33mm (25G x 1.3 in). The BVI Soft T (November 30, 2018)
  • Z-2740-2018 Class II — Slit Knife 2.6mm 45degree Bevel Up, Model Number 373726. for use in ophthalmic s (June 18, 2018)
  • Z-2342-2018 Class II — Safety Sideport Knife 1.0mm 45¿, REF 378210 Product Usage: Indicated to make (May 14, 2018)