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Recall Observatory FDA recall evidence

Device product

Karl Storz SE & CO. KG, REF 115400S, Optical Scissor, CE

Z-1473-2024

February 27, 2024

Class II

Product summary

Firm
Karl Storz Endoscopy
Event
Event 94171
Status
Ongoing
Classification
Class II
Quantity
27 units
Official record key
device-enforcement:Z-1473-2024

Official wording

Reason: Inadequate reprocessing validation evidence

Code information: UDI: 04048551259788/ All Lots

Distribution pattern: US Nationwide distribution in the states of AR, CA, CO, CT, DC, FL, GA, IA, IL, LA, MA, MI, MN, MO , ND, NY, OH, OR, SD, TN, TX, UT, VA, WA, WV.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Inadequate reprocessing validation evidence