Z-2049-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- July 21, 2021
- Initiation Date
- April 30, 2021
- Termination Date
- February 5, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 40
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.
Distribution Pattern
The products were distributed to the following US states: FL, IL, TN, WI
Code Information
Lot Numbers: F180264