FDA-Device2016-06-15Class II
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
Medical Components, Inc dba MedComp
Hazard
This recall has been initiated due to the product labeled with the incorrect expiration date.
Sold states
US Distributed to: FL, TX, NC
Affected count
VS203 Lot# MBZX140 (100 units); VS303 Lot # MBZL450 (60 units); VS303 Lot # MBZV930 (65 units); VS303 Lot # MBZZ490 (33 units).
Manufactured in
1499 Delp Dr, N/A, Harleysville, PA, United States
Products
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1924-2016Don't want to check this manually?
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