Device product

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

Z-1149-2019

March 13, 2019

Class II

Product summary

Firm: Medical Components, Inc dba MedComp
Event: Event 82415
Status: Terminated
Classification: Class II
Quantity: 6830
Official record key: device-enforcement:Z-1149-2019

Official wording

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

Code information: 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

Distribution pattern: Distributed to accounts in CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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