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RanD S.r.l. recalls Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099.
Recalled July 21, 2021 · FDA recall Z-2049-2021 · RanD S.r.l
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. · FDA Class II
Units
40
Sold at
The products were distributed to the following US states: FL, IL, TN, WI
Description
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.
Product
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
Manufacturer(s)
RanD S.r.l.
Made in
Italy
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →