Home / Recalls / Vygon Corporation / Z-1805-2012

Z-1805-2012 Class II Terminated

Recalled by Vygon Corporation — Montgomeryville, PA

FDA device recall Z-1805-2012 was initiated by Vygon Corporation on May 11, 2012 and is designated Class II. Reason for recall: Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and … The recall status is terminated (terminated March 11, 2013).

Recall Details

Product Type
Devices
Report Date
June 20, 2012
Initiation Date
May 11, 2012
Termination Date
March 11, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity

Product Description

Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

Reason for Recall

Manufacturer issued a voluntary recall on multiple lots of VY(TM)Flush Heparin Lock Flush Syringes therefore Vygon has subsequently initiated a recall on Vygon branded Heparin Lock Flush Syringes and kits containing the syringes.

Distribution Pattern

Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.

Code Information

Product Code AMS-8522CP-3 - lot 10K50.

Other recalls by Vygon Corporation

  • Z-0113-2015 Class II — Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; (August 28, 2014)
  • Z-0937-2013 Class II — Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Tr (December 17, 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-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-1803-2012 Class II — Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes inclu (May 11, 2012)
  • Z-1806-2012 Class II — Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes includ (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)

FDA data resources