Recall Z-1475-2023— Steris Corporation
Class II · Ongoing
Class II FDA medical device recall by Steris Corporation, initiated 2023-03-17. FDA's recall record names no specific 510(k) clearance for this event. Product: Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control. REF: LB53. Reason: 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 in an injury to the patient.
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2023-03-17
- Firm location
- Mentor, OH, United States
Product description
Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit over surgical light handles for sterile surgeon control. REF: LB53
Reason for recall
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 in an injury to the patient
Data sourced from openFDA. This site is unofficial and independent of the FDA.