Klinika Mdical Gmb recalls KliniTray Platte Faxitron

Potential for microbial contamination.

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 affected stock.

• FDA enforcement recordOfficial FDA database entry for Z-1769-2025
• FDA device classification · FMHOfficial FDA classification for this device type
• CFR regulation · 21 CFR 864.3250The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Klinika Mdical GmbSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.