FDA recall Z-2215-2019

Product

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

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

US Nationwide Distribution 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

2019-08-14

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-2215-2019