Home › STERIS CORPORATION › NA
NA
STERIS CORPORATION · Model LB85 · UDI-DI 00724995203399
FTA
Prescription
10
510(k) clearances
373
Adverse events
5
Recalls
89
Facilities
Description
The Sterile The STERIS Sterile Camera Handle Covers are designed for HarmonyAIR 4K Camera Module, and provide sterile Control that allow for increasing and decreasing illumination through seven intensity Levels.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsData 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.