Recall Z-0937-2013— Vygon Corporation

Name: FDA recall Z-0937-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-17

Class II · Terminated

Class II FDA medical device recall by Vygon Corporation, initiated 2012-12-17, terminated 2014-01-14. It names one FDA 510(k) clearance: K081904. Product: Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.. Reason: 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: Vygon Corporation
Classification: Class II
Status: Terminated
Initiated: 2012-12-17
Terminated: 2014-01-14
Firm location: Lansdale, 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

Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.

Reason for recall

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.