FDAApril 30, 2021device
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
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.
What to do
FDA enforcement status: Terminated
Brands named
rand s r lrand
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
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