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Medical Components, Inc dba MedComp recalls Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M
Recalled September 5, 2018 · FDA recall Z-2938-2018 · Medical Components, Inc
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. · FDA Class II
Units
N/A
Sold at
Nationwide distribution; worldwide distribution.
Description
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.
Product
Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M
Manufacturer(s)
Medical Components, Inc dba MedComp
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →