Recall Z-0898-2013— Medical Components, Inc dba MedComp

Name: FDA recall Z-0898-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-13

Class II · Terminated

Class II FDA medical device recall by Medical Components, Inc dba MedComp, initiated 2012-12-13, terminated 2013-07-31. It names one FDA 510(k) clearance: K081904. Product: REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits. Reason: The affected product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle..

Recalling firm: Medical Components, Inc dba MedComp
Classification: Class II
Status: Terminated
Initiated: 2012-12-13
Terminated: 2013-07-31
Firm location: Harleysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K081904 — PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY)Medcomp·cleared 2008-09-23

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

REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits

Reason for recall

The affected product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.

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