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Recall Observatory FDA recall evidence

Device product

Steris Lighting and Visualization Systems, Sterile Light handle Cover LB44 -Sterilizable consumables (disposable, single use) used to drape the lighthandle of STERIS surgical lighting systems for the purpose of maintaining a sterile surgical environment. REF: LB44

Z-1476-2023

March 17, 2023

Class II

Product summary

Firm
Steris Corporation
Event
Event 92040
Status
Ongoing
Classification
Class II
Quantity
263,280 covers
Official record key
device-enforcement:Z-1476-2023

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: 00724995192570 Lot Numbers: 9943616 / 9943616A 9943617 / 9943617A 9943619 / 9943619A 9943620 / 9943620A 9959650 / 9959650A 9959651 / 9959651A

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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