Recall Z-1271-2018— Medical Components, Inc dba MedComp

Name: FDA recall Z-1271-2018
Creator: U.S. Food and Drug Administration
Published: 2017-11-22

Class II · Terminated

Class II FDA medical device recall by Medical Components, Inc dba MedComp, initiated 2017-11-22, terminated 2018-07-11. It names one FDA 510(k) clearance: K132177. Product: 8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter. Reason: The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire..

Recalling firm: Medical Components, Inc dba MedComp
Classification: Class II
Status: Terminated
Initiated: 2017-11-22
Terminated: 2018-07-11
Firm location: Harleysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K132177 — MEDCOMP GEN III POWER INJECTABLE PORTMedcomp ( Medical Components)·cleared 2013-12-12

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

8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter

Reason for recall

The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.

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