Steris Corporation: Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical light

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: 263,280 covers Lot/code info: GTIN number: 00724995192570 Lot Numbers: 9943616 / 9943616A 9943617 / 9943617A 9943619 / 9943619A 9943620 / 9943620A 9959650 / 9959650A 9959651 / 9959651A

UPC codes

00724995192570

Source

Official record: FDA (Device enforcement) ↗

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