FDA-Device2021-10-06Class II
Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995
Angiodynamics Inc. (Navilyst Medical Inc.)
Hazard
Mislabeled: The product is labeled as 5F (55cm; Maximum Flow Rate 3.5 mL/Sec) and the product is actually 4F (55cm; Maximum Flow Rate 3.5 mL/Sec).
Sold states
Canada
Affected count
4 boxes (5/each)= 20 eaches
Manufactured in
10 Glens Falls Tech Park, N/A, Glens Falls, NY, United States
Products
Xcela PICC with PASV Valve Technology/Kit 5 F-55cm; (Maximum Flow Rate 3.5 mL/Sec)-indicated for short or long-term peripheral access to the central venous system for intravenous therapy, including but not limited to, the administration of fluids, medications, and nutrients; the sampling of blood; and for power injection of contrast media. Catalog Number: 60M701995
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2617-2021Don't want to check this manually?
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