FDAClass IISeptember 5, 2018

Soft-line Duo-flow Double Lumen Catheter/catheter SET recall

SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M

Why was Soft-line Duo-flow Double Lumen Catheter/catheter SET 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?

MCDA290 MHLQ370 MHMZ270 MHSN190 MHTH950 MHTR800 MHXL900 MJAT510 MJAZ020 MJBL200 MJCV760 MJFP340 MJGC620 MJGX680 MJKN210 MJLP090 MLDF860 MHLL060 MHND620 MHPA230 MHQZ510 MHSR590 MHXJ990 MHYS090 MJDW030 MJGK930 MJGX690 MJJF710 MLBA570 MLBK460 MLCT650 MHKJ180 MHMJ970 MHPK440 MHRN870 MJBP190 MJHJ860 MLBG870

Product
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M
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