Z-3045-2018Class II

Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000

Name: Z-3045-2018 Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000
Creator: Beaver Visitec
Published: 2018-07-19
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2018-07-19 / Terminated / root cause: manufacturing process

FDA source

Beaver Visitec began a recall of 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... on 2018-07-19. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-3045-2018
Classification: Class II
Status: Terminated
Initiated: 2018-07-19
Posted: 2018-09-13
Terminated: 2019-05-23
Recalling firm: Becton Dickinson & Co
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.
Product code: HQP Unit, Cautery, Thermal, Battery-Powered
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
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
Quantity in commerce: 800 units
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.
Product codes and lots: Lot 6002809, UDI 8445000 30886158010297

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3045-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3045-2018	Class II	Terminated	Voluntary: Firm initiated	2018-09-19	2018-09-13

Product code HQP

K771189Class IIHot Temp CauteryEdward Weck, Inc. / cleared 1977-07-11

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)