Percutaneous Intravenous Catheter Repair Kit

• 3 recalls, same reason

  • Terminated Z-1067-03 FDA Unclassified (pre-2012) ·initiated 8 Jul 2003 ·on shared 510(k) K904334
  • Terminated Z-1068-03 FDA Unclassified (pre-2012) ·initiated 8 Jul 2003 ·on shared 510(k) K904334
  • Terminated Z-1066-03 FDA Unclassified (pre-2012) ·initiated 8 Jul 2003 ·on shared 510(k) K904334

  Silicone adhesive in kits used to repair damaged catheters did not set (cure) properly and remained in a tacky state.

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

510(k) Number

K904334 ↗

FDA Product Code

LJS

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

FDA Decision

SESK Substantially Equivalent — Kit

• The Gripper Seal(Tm)

  Class I

  FDA 510(k) K870900 Active Cleared 31 Mar 1987

• Pharmacia Deltec Peripherally Inserted Venous Cath

  Class II

  FDA 510(k) K926544 Active Cleared 21 Mar 1994

• Port-A-Cath Implantable Drug Delivery System

  Class II

  FDA 510(k) K903220 Active Cleared 10 Oct 1990

• Lockbox

  Class II

  FDA 510(k) K900888 Active Cleared 15 May 1990

• Port-A-Cath Implantable Vascular Access System

  Class II

  FDA 510(k) K932840 Active Cleared 5 Jan 1994

• Model 1330 Extension Set

  Class II

  FDA 510(k) K873042 Active Cleared 23 Oct 1987

See all devices from Pharmacia Deltec, Inc. →