Recall Z-1868-2012— Medical Components, Inc dba MedComp

Name: FDA recall Z-1868-2012
Creator: U.S. Food and Drug Administration
Published: 2012-04-02

Class II · Terminated

Class II FDA medical device recall by Medical Components, Inc dba MedComp, initiated 2012-04-02, terminated 2013-05-20. It names one FDA 510(k) clearance: K070003. Product: MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.. Reason: Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port..

Recalling firm: Medical Components, Inc dba MedComp
Classification: Class II
Status: Terminated
Initiated: 2012-04-02
Terminated: 2013-05-20
Firm location: Harleysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K070003 — POWER INJECTABLE IMPLANTABLE INFUSION PORT WITH SILICONE LUMEN (ATTACHABLE AND PRE-ATTACHED)Medcomp·cleared 2007-05-15

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

MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.

Reason for recall

Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.

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