FDA recall Z-1149-2019

Medical Components, Inc dba MedComp · Class II · device

Product

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

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2019-03-13
Report date
2019-04-24
Termination date
2024-03-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Harleysville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1149-2019