Ultraflex Infusion Set

• 11 recalls, same reason

  • Terminated Z-1118-06 FDA Unclassified (pre-2012) ·initiated 31 Mar 2006 ·on shared 510(k) K033892
  • Terminated Z-1120-06 FDA Unclassified (pre-2012) ·initiated 31 Mar 2006 ·on shared 510(k) K033892
  • Terminated Z-1125-06 FDA Unclassified (pre-2012) ·initiated 31 Mar 2006 ·on shared 510(k) K033892
  • Terminated Z-1119-06 FDA Unclassified (pre-2012) ·initiated 31 Mar 2006 ·on shared 510(k) K033892
  • Terminated Z-1117-06 FDA Unclassified (pre-2012) ·initiated 31 Mar 2006 ·on shared 510(k) K033892
  • Terminated Z-1127-06 FDA Unclassified (pre-2012) ·initiated 31 Mar 2006 ·on shared 510(k) K033892
  • Terminated Z-1122-06 FDA Unclassified (pre-2012) ·initiated 31 Mar 2006 ·on shared 510(k) K033892
  • Terminated Z-1126-06 FDA Unclassified (pre-2012) ·initiated 31 Mar 2006 ·on shared 510(k) K033892
  • Terminated Z-1116-06 FDA Unclassified (pre-2012) ·initiated 31 Mar 2006 ·on shared 510(k) K033892
  • Terminated Z-1123-06 FDA Unclassified (pre-2012) ·initiated 31 Mar 2006 ·on shared 510(k) K033892
  • Terminated Z-1121-06 FDA Unclassified (pre-2012) ·initiated 31 Mar 2006 ·on shared 510(k) K033892

  The luer tube may break at the lock-tubing connection to the pump, causing an interruption of insulin delivery, which can and has contributed to hyperglycemia

• • Terminated Z-1124-06 FDA Unclassified (pre-2012) ·initiated 31 Mar 2006 ·on shared 510(k) K033892

  The luer tube may break at the connection to the pump and, if this is not noticed by the patient, the patient may receive an under delivery of insulin.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K033892 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Disetronic Rapid Subcutaneous Infusion Set and Disteronic Rapid D Subcutaneous Infusion Set

  Class II

  FDA 510(k) K003977 Active Cleared 15 Feb 2001

• Modification to D-Tronplus

  Class II

  FDA 510(k) K043000 Active Cleared 1 Dec 2004

• Modification to Disetronic D-Tronplus Insulin Infusion Pump

  Class II

  FDA 510(k) K022831 Active Cleared 11 Sep 2002

• Disetronic D-Modem

  Class II

  FDA 510(k) K943952 Active Cleared 7 Oct 1995

• Disetronic Pen

  Class II

  FDA 510(k) K982966 Active Cleared 19 Oct 1998

• Disetronic Multifuse Infusion Pump System

  Class II

  FDA 510(k) K001629 Active Cleared 21 Jun 2000

See all devices from Disetronic Medical Systems →