Recall Z-0363-2025 ยท NVT Tubing And Tubing/Filter Fits
Karl Storz Endoscopy
Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set, Irrigation, PC
| Date | Nov 12, 2024 (initiated Oct 21, 2024) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling design |
| Action | On 10/22/2024, an "URGENT: MEDICAL DEVICE CORRECTION" Letters will be sent via email by KARL STORZ informing customers that the firm has become aware that one lot number of misbranded product was distributed to 19 customers. Customers are instructed to: 1. Pass on this Urgent Medical Device Correction to all users of the products listed above (Table 1) and all other persons who need to be aware within your organization. 2. Communicate to all applicable users that the product is not to be utilized during spinal procedures. 3. If you have or may have distributed the products listed, please ide |
| Quantity | 40 units |
| Distribution | U.S. Nationwide distribution in the states of CO, CT, DC, MD, MI, MN, NC, NY, OH, OK, TN, TX, WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.