FDAClass IIAugust 14, 2019

14F x 24CM SLX Double Lumen Full Tray Hemodialysis recall

14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis…

Why was 14F x 24CM SLX Double Lumen Full Tray Hemodialysis recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

MCAL430 MCAT000 MCBM770 MCBS380 MCCC840 MCCM930 MCCS360 MCCZ450 MCDC580 MCDN120 MCDR420 MCFB350 MCFG980 MCFM410 MCFP230 MCFT430 MCFZ290 MKAF350 MKAG490 MKAM210 MKAR120 MKBA200 MKBL090 MKBL220 MKBV580 MMAB710 MMAM070 MMAQ950

Product
14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis…
Recalling firm
Medical Components, Inc dba MedComp
Quantity
6830
Distribution
US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
Recall date
August 14, 2019
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls