FDA-Device2021-07-21Class II
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
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.
Sold states
The products were distributed to the following US states: FL, IL, TN, WI
Affected count
40
Manufactured in
Strada Statale 62, Medolla, Italy
Products
Ch24 round silicone catheter, Diameter: 8 mm, Perforated section: 230 mm, Total length: 600 mm, Reference Code R9900099. Thoracic/abdominal cavity drain catheter.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2049-2021Don't want to check this manually?
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