Reported Sep 5, 2018 · Terminated
Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
Medical Components, Inc. dba MedComp
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medical Components, Inc dba MedComp · 1499 Delp Dr · Harleysville, PA · 19438-2936
Is this the product you have?
- Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
- Lot codes and dates
- MCBA810 MCBS660 MCAX580 MCBH13D MCBKOlO
MCBN350MCBY390MCCV240MCDA860MCDG370MCDJ730MCDP710MCFA850MCFB360MCFD630MCFM700MCFS710MCFX790MKAD790MKAG470MKAT090MKAX630MCBA820MCBYS20MCCP980MCFD640MCFQ350MKAR100MCAC610MCAT590MCCH750MCDQ920MCFV690MCAH750MCFZ550
- MCBA810 MCBS660 MCAX580 MCBH13D MCBKOlO
- Amount recalled
- N/A
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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