Recall Z-1123-2018— Medical Components, Inc dba MedComp

Name: FDA recall Z-1123-2018
Creator: U.S. Food and Drug Administration
Published: 2018-02-23

Class II · Terminated

Class II FDA medical device recall by Medical Components, Inc dba MedComp, initiated 2018-02-23, terminated 2020-01-10. It names one FDA 510(k) clearance: K022570. Product: 12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 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.. Reason: 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..

Recalling firm: Medical Components, Inc dba MedComp
Classification: Class II
Status: Terminated
Initiated: 2018-02-23
Terminated: 2020-01-10
Firm location: Harleysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K022570 — MEDCOMP REPAIR KIT, MODEL ASPCRPKMedcomp·cleared 2002-10-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

12F MODIFIED Tesio CATHETER SET, REF MCTC1235SM, UDI 884908027259 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.

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.