Z-2935-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 5, 2018
- Initiation Date
- July 12, 2018
- Termination Date
- July 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
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.
Distribution Pattern
Nationwide distribution; worldwide distribution.
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