L-Cath Peel Away System Catheter

• 7 recalls, same reason

  • Terminated Z-0283-06 FDA Unclassified (pre-2012) ·initiated 25 Mar 2005
  • Terminated Z-0282-06 FDA Unclassified (pre-2012) ·initiated 25 Mar 2005
  • Terminated Z-0285-06 FDA Unclassified (pre-2012) ·initiated 25 Mar 2005
  • Terminated Z-0284-06 FDA Unclassified (pre-2012) ·initiated 25 Mar 2005
  • Terminated Z-0288-06 FDA Unclassified (pre-2012) ·initiated 25 Mar 2005
  • Terminated Z-0287-06 FDA Unclassified (pre-2012) ·initiated 25 Mar 2005
  • Terminated Z-0286-06 FDA Unclassified (pre-2012) ·initiated 25 Mar 2005

  Aspiration (blood return) could not be achieved on some L-Cath 16 gauge catheters.

• 3 recalls, same reason

  • Terminated Z-0784-04 FDA Unclassified (pre-2012) ·initiated 9 Mar 2004
  • Terminated Z-0785-04 FDA Unclassified (pre-2012) ·initiated 9 Mar 2004
  • Terminated Z-0783-04 FDA Unclassified (pre-2012) ·initiated 9 Mar 2004

  Catheters have stylets extending past the catheter tip, which, if not noticed could cause injury upon insertion.

510(k) Number

K920755 ↗

FDA Product Code

LJS

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

• L-Cath Intravenous Placement Unit

  Class II

  FDA 510(k) K801575 Active Cleared 20 Aug 1980

• L-Cath Peel-Away Catheter System

  Class II

  FDA 510(k) K924968 Active Cleared 21 May 1993

• Onecath L-Cath Catheter System

  Class II

  FDA 510(k) K930473 Active Cleared 7 Apr 1994

• L-Cath Modified Seldinger Technique Insertion/Catheter Exchange Kit Pe-MST24-24 Ga. Kit, L-Cath Modified Seldinger

  Class II

  FDA 510(k) K974543 Active Cleared 10 Feb 1998

• Thermotherapy

  Unclassified

  FDA 510(k) K822217 Active Cleared 24 Sep 1982

• Lumed Expando-Cath, Activ

  Class II

  FDA 510(k) K884806 Active Cleared 8 Feb 1989

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