Z-0363-2025 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 20, 2024
- Initiation Date
- October 21, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40 units
Product Description
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
Reason for Recall
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.
Distribution Pattern
U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA.
Code Information
Product/Material Number: 031523-10 UDI-DI code: 04048438006306 Lot Number: 240222