Medical Components, Inc dba MedComp recalls 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for…

Recall date

March 13, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2215-2019

FDA classification

Class II

Brand / firm

Medical Components, Inc dba MedComp

Sold / distributed

US Nationwide Distribution 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.

What was recalled

14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter