Device product
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Z-0363-2025
Product summary
- 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
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.