Device product
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
Z-2049-2021
Product summary
- Firm
- RanD S.r.l.
- Event
- Event 87926
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40
- Official record key
device-enforcement:Z-2049-2021
Official wording
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.
Code information: Lot Numbers: F180264
Distribution pattern: The products were distributed to the following US states: FL, IL, TN, WI
Derived failure modes
-
Unknown
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.