FDA-Device2019-04-24Class II
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Medical Components, Inc dba MedComp
Hazard
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Sold states
Distributed to accounts in CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
Affected count
6830
Manufactured in
1499 Delp Dr, N/A, Harleysville, PA, United States
Products
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1149-2019Don't want to check this manually?
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