FDA-Device2015-06-17Class II
Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.
Smiths Medical Asd Inc
Hazard
Smiths Medical has become aware of an issue with the Low Volume Extension Set, (72'' Extension Set) where under-sized tubing was used in the production of 1 lot of product.
Sold states
Distributed to the states of KY, MN, NJ, UT, & WI.
Affected count
6,000 units
Manufactured in
6250 Shier Rings Rd, N/A, Dublin, OH, United States
Products
Low Volume Extension Set, 72' w/Clamp FLL/MLL APV=1.3ml, STERILE, AND FLUID PATH NONPYROGENIC UNLESS PACKAGE IS DAMAGED OR OPENED. LATEX FREE, SINGLE USE Tyvek pouches, 10 per box, Smiths Medical ASD, Inc. Used to administer fluid and drugs intravenously.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1730-2015Don't want to check this manually?
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