FDA recall Z-1475-2023

Steris Corporation · Class II · device

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 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

Distribution

Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.

Key facts

Status: Ongoing
Initiation date: 2023-03-17
Report date: 2023-05-10
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mentor, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1475-2023