RegWardenFDA facility compliance records
Recall

Class II — Medical Components, Inc dba MedComp

Recalling firmMedical Components Inc
Registered facilityView this company's 2 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonTray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Product14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Quantity6830
DistributionDistributed to accounts in CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
Initiated2019-03-13
Classified2019-04-16
Terminated2024-03-05
Recall numberZ-1149-2019
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — Medical Components, Inc dba MedComp (Z-1149-2019).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/82415/

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