Steris Corporation: Steris Lighting and Visualization Systems, Sterile Light Handle Cover (LB53)- Surgical light handle covers, including disposable surgical light handle covers are designed to fit ov

Hazard

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 from the source

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. Quantity: 1,358,520 covers Lot/code info: GTIN number: 00724995150136 Lot Numbers: 9604187 / 9604187A 9604188 / 9604188A 9604189 / 9604189A 9604190 / 9604190A 9604191 / 9604191A 9799082 / 9799082A 9799083 / 9799083A 9799084 / 9799084A 9799085 / 9799085A 9799086 / 9799086A 9799087 / 9799087A 9799088 / 9799088A 9799089 / 9799089A 9799090 / 9799090A 9799091 / 9799091A 9799092 / 9799092A 9799093 / 9799093A 9799094 / 9799094A 9799095 / 9799095A 9799096 / 9799096A 9799097 / 9799097A 9799098 / 9799098A 9799099 / 9799099A 9799100 / 9799100A 9799101 / 9799101A 9799102 / 9799102A 9799103 / 9799103A 9799104 / 9799104A 9799105 / 9799105A 9799106 / 9799106A 9799107 / 9799107A 9799108 / 9799108A

UPC codes

00724995150136

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.