Medical Components, Inc dba MedComp: Medical Device Recall in 2018 - (Recall #: Z-2935-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ

Product Classification:

Class II

Date Initiated: July 12, 2018

Date Posted: September 5, 2018

Recall Number: Z-2935-2018

Event ID: 80581

Reason for Recall:

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.

Status: Terminated

Product Quantity: N/A

Code Information:

MCBA810 MCBS660 MCAX580 MCBH13D MCBKOlO MCBN350 MCBY390 MCCV240 MCDA860 MCDG370 MCDJ730 MCDP710 MCFA850 MCFB360 MCFD630 MCFM700 MCFS710 MCFX790 MKAD790 MKAG470 MKAT090 MKAX630 MCBA820 MCBYS20 MCCP980 MCFD640 MCFQ350 MKAR100 MCAC610 MCAT590 MCCH750 MCDQ920 MCFV690 MCAH750 MCFZ550

Distribution Pattern:

Nationwide distribution; worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated