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Recall Observatory FDA recall evidence

Device product

Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ

Z-2935-2018

July 12, 2018

Class II

Product summary

Firm
Medical Components, Inc dba MedComp
Event
Event 80581
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-2935-2018

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.