Medolla, Italy
RanD S.r.l. recalls
1 recall recorded since 2018, most recently on 30 April 2021. 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
- 30 April 2021
- Terminated
- 5 February 2024
- Reason
- The sterilization contractor informed the company of a quality issue possibly affecting the sterilization process of a certain number of products. It was determined that some lots may not be sterile.
- Distribution
- The products were distributed to the following US states: FL, IL, TN, WI
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2048-2021, Z-2049-2021
- Hang&Go (kit for hyperthermic perfusion), Reference Code R9900120
- Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
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.