Home / Recalls / Vygon Corporation / Z-0937-2013

Z-0937-2013 Class II Terminated

Recalled by Vygon Corporation — Lansdale, PA

Recall Details

Product Type
Devices
Report Date
March 20, 2013
Initiation Date
December 17, 2012
Termination Date
January 14, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
210

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.

Distribution Pattern

Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania

Code Information

Lots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015.

Other recalls by Vygon Corporation

  • Z-0113-2015 Class II — Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; (August 28, 2014)
  • Z-1802-2012 Class II — Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled (May 11, 2012)
  • Z-1798-2012 Class II — Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Fl (May 11, 2012)
  • Z-1799-2012 Class II — Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Fl (May 11, 2012)
  • Z-1797-2012 Class II — Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flus (May 11, 2012)
  • Z-1807-2012 Class II — Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes includ (May 11, 2012)
  • Z-1801-2012 Class II — Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL F (May 11, 2012)
  • Z-1808-2012 Class II — Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled (May 11, 2012)
  • Z-1803-2012 Class II — Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes inclu (May 11, 2012)
  • Z-1800-2012 Class II — Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 3mL in a 10mL F (May 11, 2012)