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Aspen® Rigid Light Handle Cover
ASPEN SURGICAL PRODUCTS, INC. · Model LT-R01 · UDI-DI 00840113201280
1
510(k) clearances
369
Adverse events
5
Recalls
89
Facilities
Description
Single use, sterile. Provides a sterile interface between the operating room surgical lamps (non-sterile) and the Surgeon or Nurse (sterile).
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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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.