Beaver Accu-Temp High Temperature Cautery Recalled for Sterility Risk
Beaver Visitec is recalling 800 units of Accu-Temp High Temperature Cautery devices due to a potential loss of sterility caused by packaging defects.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (loss of sterility) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Beaver Visitec is recalling 800 units of the Beaver Accu-Temp High Temperature Cautery, 2 inch Shaft with Fine Tip, Model Number 8445000. The recall affects Lot 6002809, which was distributed worldwide, including in the United States and in Australia, France, the Netherlands, Spain, and the United Kingdom.
The recall was initiated because a small number of devices in this lot may have a melted cap and a hole formed through the packaging. This defect poses a risk that the product may no longer be sterile for use, which could potentially cause harm to a patient.
Healthcare providers and facilities should check their inventory for this specific lot number and discontinue use of any affected units. The devices are intended for coagulating tissue or arresting bleeding from small vessels by heat in ophthalmic, general, and plastic surgery.
The recalled product
- 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.…
- Manufacturer
- Beaver Visitec
- Affected units
- 800
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 6002809
- UDI 8445000 30886158010297
Distribution
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