Catheter Innovations Implantable Port

• 2 recalls, same reason

  • Terminated Z-0343-06 FDA Unclassified (pre-2012) ·initiated 28 Oct 2005 ·on shared 510(k) K991897
  • Terminated Z-0344-06 FDA Unclassified (pre-2012) ·initiated 28 Oct 2005 ·on shared 510(k) K991897

  Device kits contain B. Braun Locking Tearaway Introducer Systems labeled as 7Fr but may contain 8 Fr sheaths.

• 6 recalls, same reason

  • Terminated Z-1517-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K991897
  • Terminated Z-1514-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K991897
  • Terminated Z-1513-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K991897
  • Terminated Z-1512-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K991897
  • Terminated Z-1516-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K991897
  • Terminated Z-1515-05 FDA Unclassified (pre-2012) ·initiated 22 Jul 2005 ·on shared 510(k) K991897

  The Tearaway Introducer Sheath may have cracked hubs/handles and/or improper peeling during use.

• • Terminated Z-0847-04 FDA Unclassified (pre-2012) ·initiated 29 Mar 2004 ·on shared 510(k) K991897

  Catheters may not have adequate radiopacity for proper visualization under fluoroscopy.

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

510(k) Number

K991897 ↗

FDA Product Code

LJT

Device Class

Class II

Regulation

21 CFR Part 880.5965

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• Pasv Dual Lumen Peripherally Inserted Midline Catheter Model Number Midline-Numerous

  Class II

  FDA 510(k) K981382 Active Cleared 1 May 1998

• Pasv Dual Lumen Peripherally Inserted Central Catheter (Picc) Model Number Pic-Numerous

  Class II

  FDA 510(k) K981368 Active Cleared 1 May 1998

• 6 Inch Mini-Bone Extension Set with Luer Lock, NES01S, 6 Inch Min-Bone Extension Set with Luer Slip, NES02S, 6 Inch Stat

  Class II

  FDA 510(k) K980127 Active Cleared 11 Mar 1998

• Dual Lumen Midline Catheter

  Class II

  FDA 510(k) K010349 Active Cleared 28 Feb 2001

• Placement-Plus

  Class II

  FDA 510(k) K003642 Active Cleared 20 Dec 2000

• Vaxcel Picc with Pasv Valve Technology

  Class II

  FDA 510(k) K021704 Active Cleared 6 Jun 2002

See all devices from Catheter Innovations, Inc. →