Recall Z-1527-2015— Medical Components, Inc dba MedComp

Name: FDA recall Z-1527-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-28

Class II · Terminated

Class II FDA medical device recall by Medical Components, Inc dba MedComp, initiated 2015-01-28, terminated 2017-01-06. It names one FDA 510(k) clearance: K000125. Product: 9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.. Reason: The dual port with catheters was not covered under FDA clearance..

Recalling firm: Medical Components, Inc dba MedComp
Classification: Class II
Status: Terminated
Initiated: 2015-01-28
Terminated: 2017-01-06
Firm location: Harleysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K000125 — JET PORT PLUS CATHETER SYSTEMClinical Plastic Products SA·cleared 2000-04-12

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

9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.

Reason for recall

The dual port with catheters was not covered under FDA clearance.

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