KliniTray. KlinioTray. Tissue resection margin examination board/small. Model Number: 2001105-F The medical device Klini
FDA device recall Z-1768-2025 · posted 2025-05-15 · Open, Classified
Recall details
- Recalling firm
- Klinika Mdical Gmb
- Reason for recall
- Potential for microbial contamination.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FMH
- Quantity affected
- 620 units
- Distribution
- US Nationwide distribution in the state of Massachusetts.
- Date initiated
- 2025-04-04
- Date posted
- 2025-05-15
- Location
- Usingen, Germany
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