Recall Z-2049-2021— RanD S.r.l.
Class II · Terminated
Class II FDA medical device recall by RanD S.r.l., initiated 2021-04-30, terminated 2024-02-05. FDA's recall record names no specific 510(k) clearance for this event. Product: Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.. 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..
- Recalling firm
- RanD S.r.l.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-04-30
- Terminated
- 2024-02-05
- Firm location
- Medolla, Italy
Product description
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.