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STERIS CORPORATION · Model Sterile Lighthandle Cover · UDI-DI 00724995150136

FTA

510(k) clearances

373

Adverse events

Recalls

Facilities

Description

The STERIS Sterile LightHandle Covers are designed for HarmonyAIR surgical lights, and provide sterile Control that allow for increasing and decreasing illumination through seven intensity Levels. They are compatible with all Harmony and HarmonyAIR Surgical Lights.

Recalls

Date	Firm	Reason
2023-03-17	Steris Corporation	Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result i
2023-03-17	Steris Corporation	Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result i
2017-10-13	Ecolab, Inc.	Sterile packaging of the disposable light handle cover may contain gaps in the seal of the pouch.
2007-02-13	Sunnex Inc.	Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.
2007-02-13	Sunnex Inc.	Surgical and/or exam lamp holder may malfunction, discolor, melt and smolder.

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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.