Recall Z-1768-2025 ยท FMH Container, Specimen, Sterile
Klinika Mdical Gmb
KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device KliniTrayTM is a system for the precise monitoring, recording and visualization of alignment during surgical procedures. It ensures the exact orientation and positioning of tissue to be removed in the patient's body, enabling improved surgical precision and patient safety.
| Date | May 15, 2025 (initiated Apr 4, 2025) |
| Status | Open, Classified |
| Reason | Potential for microbial contamination. |
| Root cause | Process control |
| Action | Single distributor was notified via email on 04/04/2025 with an "URGENT FIELD SAFETY NOTICE - PRODUCT RECALL" letter. The letter instructed the distributor to Identify and quarantine all units of the affected LOT numbers, do not distribute or use these products, treat the products as non-sterile (clean packed) and ensure they are not used on the sterile field, and inform all relevant departments or customers within your distribution chain about this FSCA. Additionally, the distributor was requested to complete and return the acknowledgment form by 04/16/2025, even if you no longer have affec |
| Quantity | 620 units |
| Distribution | US Nationwide distribution in the state of Massachusetts. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.