Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-2936-2018 — Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits

U.S. FDA — Device Enforcement · United States · 2018-07-12 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2936-2018
Date of alert
2018-07-12
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medical Components, Inc dba MedComp
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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