RanD S.r.l. recalls Ch24 round silicone catheter, Diameter: 8 mm, Perforated sec
Recalled Product
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
Hazard / Issue
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.
Issued by
FDA
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