Z-0363-2025 Class II Ongoing
FDA device recall Z-0363-2025 was initiated by Karl Storz Endoscopy on October 21, 2024 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 40 units.
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