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Bovie

ASPEN SURGICAL PRODUCTS, INC. · Model AA00 · UDI-DI 10887482175160

HQP Prescription

510(k) clearances

106

Adverse events

Recalls

Facilities

Description

Cautery Low Temp Fine Tip 10/bx

Recalls

Date	Firm	Reason
2018-07-19	Beaver Visitec	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 c
2004-06-29	Aaron Medical Industries, Inc.	The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.
2004-06-29	Aaron Medical Industries, Inc.	The cover caps on some of these cauteries are not properly engaged to prevent inadvertent activation.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.