Spetzler Lumbar-Peritoneal System

• 5 recalls, same reason

  • Terminated Z-1047-201 FDA Unclassified (pre-2012) ·initiated 28 Nov 2011
  • Terminated Z-1049-2012 FDA Unclassified (pre-2012) ·initiated 28 Nov 2011
  • Terminated Z-1048-2012 FDA Unclassified (pre-2012) ·initiated 28 Nov 2011
  • Terminated Z-1051-2012 FDA Unclassified (pre-2012) ·initiated 28 Nov 2011
  • Terminated Z-1050-2012 FDA Unclassified (pre-2012) ·initiated 28 Nov 2011

  The current packaging configuration for the non-sterile shunt accessories could lead to the potential for confusion regarding product sterility.

510(k) Number

K811288 ↗

FDA Product Code

JXG

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Ventral Wall Defect Reduct Silo

  Class II

  FDA 510(k) K840172 Active Cleared 27 Jun 1984

• Large Volume Closed Wound Suction Drain

  Class I

  FDA 510(k) K822032 Active Cleared 16 Aug 1982

• Chemotherapy Infusion Catheter

  Class I

  FDA 510(k) K822096 Active Cleared 12 Apr 1983

• American Heyer-Schulte Low Profile Valve

  Class II

  FDA 510(k) K802586 Active Cleared 18 Dec 1980

• Jackson-Pratt Large Vol. Closed Wound

  Class I

  FDA 510(k) K801766 Active Cleared 20 Aug 1980

• Heyer-Schulte Afterloading Catheter

  Class I

  FDA 510(k) K832738 Active Cleared 29 Sep 1983

See all devices from American Heyer Schulte →