Medical Components, Inc dba MedComp recalls 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422

Recall date: March 13, 2019
Source: U.S. Food & Drug Administration (FDA) — enforcement report
Recall number: Z-1149-2019
FDA classification: Class II
Brand / firm: Medical Components, Inc dba MedComp
Sold / distributed: Distributed to accounts in CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.

Why it was recalled

Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422

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