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
Reported: May 10, 2023 Initiated: March 17, 2023 #Z-1475-2023
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
Details
- Recalling Firm
- Steris Corporation
- Units Affected
- 1,358,520 covers
- Distribution
- Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.
- Location
- Mentor, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Steris Corporation. Units affected: 1,358,520 covers.
Why was this product recalled? ▼
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
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 10, 2023. Severity: Moderate. Recall number: Z-1475-2023.
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