FDA-Device2018-09-05Class II
Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
Medical Components, Inc dba MedComp
Hazard
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.
Sold states
Nationwide distribution; worldwide distribution.
Affected count
N/A
Manufactured in
1499 Delp Dr, N/A, Harleysville, PA, United States
Products
Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2936-2018Don't want to check this manually?
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