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Recall Observatory FDA recall evidence

Device product

Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC

Z-0363-2025

October 21, 2024

Class II

Product summary

Firm
Karl Storz Endoscopy
Event
Event 95607
Status
Ongoing
Classification
Class II
Quantity
40 units
Official record key
device-enforcement:Z-0363-2025

Official wording

Reason: Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.

Code information: Product/Material Number: 031523-10 UDI-DI code: 04048438006306 Lot Number: 240222

Distribution pattern: U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Due to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S.

Field note

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