Barcelona, N/A, Spain
Leventon S. A. U. recalls
1 recall recorded since 2018, most recently on 23 May 2019. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 23 May 2019
- Terminated
- 8 June 2020
- Reason
- The product lacks 510(k) clearance, and therefore is misbranded and must be removed from the U.S. market.
- Distribution
- US Distribution to states in: AZ, CA, MA, MI, PR, and FL.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2360-2019
- DOSI-FUSER 12591 5-500D1 -USA, 12591 5-600D1 -USA Provide parenteral drug infusions at a constant flow without impeding patient mobility
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.