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
Z-1475-2023
Product summary
- Event
- Event 92040
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,358,520 covers
- Official record key
device-enforcement:Z-1475-2023
Official wording
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
Code information: 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
Distribution pattern: Worldwide - US Nationwide distribution including Puerto Rico and the countries of Canada, Australia.
Derived failure modes
-
Unknown
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