Home / Recalls / Vygon Corporation / Z-0113-2015

Z-0113-2015 Class II Terminated

Recalled by Vygon Corporation — Lansdale, PA

Recall Details

Product Type
Devices
Report Date
October 29, 2014
Initiation Date
August 28, 2014
Termination Date
March 30, 2015
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
42250

Product Description

Bionector Needleless connector. Bionector is a multi-purpose catheter accessory; a closed needle-less system permitting blood sampling, intermit ant injection and continuous infusion of fluids or medications to patients in a hospital or homecare situation.

Reason for Recall

Vygon has uncovered potential problems with membrane elasticity in the 896.038, Bionector Needleless connector and is issuing a voluntary recall of the 896.038, Bionector Needleless connector.

Distribution Pattern

Worldwide Distribution - US including CA and Internationally to CA.

Code Information

Product code and lot numbers: Product Code: 896.038, with lot Numbers: 291113EE, 070214EE, 210314EE, 280314EE.

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  • 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-1806-2012 Class II — Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes includ (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)