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

Recall Z-1127-2018 — REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.

U.S. FDA — Device Enforcement · United States · 2018-02-23 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1127-2018
Date of alert
2018-02-23
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Medical Components, Inc dba MedComp
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
884908039856
Reported risk: There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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