FDAClass IISeptember 5, 2018

Soft-line Duo-flow Double Lumen Catheter Tray recall

SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424

Why was Soft-line Duo-flow Double Lumen Catheter Tray recalled?

The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.

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?

MCBH160 MCCJ940 MKAG230 MKAS240 MBZV560 MCAR110 MCBM700 MCBZ130 MCCK670 MCCV840 MCDC320 MCDH160 MCDP900 MCFB210 MCFN490 MCFP330 MCFQ160 MCFX190 MKAF070 MKAJ840 MKAS430 MKAZ840 MBZB490 MCAD070 MCBB940 MCBH000 MCBN030 MCBT690 MCCK250 MCCP870 MCDK690 MCDP260 MCFG470 MCFV940 MKAF420 MKAJ850 MKAP270 MKAT230 MCAK690 MCBD150

Product
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424
Recalling firm
Medical Components, Inc dba MedComp
Quantity
N/A
Distribution
Nationwide distribution; worldwide distribution.
Recall date
September 5, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls