FDA-Device2018-09-05Class II
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M
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
SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2940-2018Don't want to check this manually?
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