FDAFDA · Food and drugs·Recall number Z-1149-2019
14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Published April 24, 2019 · Recall initiated: March 13, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medical Components, Inc dba MedComp
- Distributor
- Distributed to accounts in CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
- Lot
- MCAL680 MCBA840 MCBH140 MCBK600 MCBY920 MCCH670 MCCR320 MCCV590 MCDG930 MCDK980 MCDR400 MCFB320 MCFG490 MCFR460 MCFT410 MCFY850 MCFZ660 MKAD410 MKAN270 MKAP300 MKAT100 MKAX320 MKBA190 MKBK940 MKBL210 MKBP450 MKBV570 MMAA170 MMAD480 MMAS020
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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