Codman Eds 3 Csf External Drainage System, Models 82-1730, 82-1731, 82-1732, 82-1733, 82-1735, 82-1738

• 3 recalls, same reason

  • Terminated Z-0090-2015 FDA Class II ·initiated 15 Sep 2014
  • Terminated Z-0089-2015 FDA Class II ·initiated 15 Sep 2014
  • Terminated Z-0091-2015 FDA Class II ·initiated 15 Sep 2014

  tubing within the system that drains CSF may leak or disconnect from the joints and may result in over- or under-drainage of CSF from the ventricular system or introduction of air into the ventricular system (pneumocephalus)

510(k) Number

K061568 ↗

FDA Product Code

JXG

Models / Variants

82-1730

82-1731

82-1732

82-1733

82-1735

82-1738

Device Class

Class II

Regulation

21 CFR Part 882.5550

Advisory Committee

Neurology

FDA Decision

SESE Substantially Equivalent

• Codman Bactiseal EVD Catheter Set

  Class II

  FDA 510(k) K021653 Active Cleared 29 Jul 2002

• Codman* External Drainage System II (Eds-II)

  Class II

  FDA 510(k) K902257 Active Cleared 19 Jul 1990

• Orbit Galaxy G2 Microcoil Delivery System

  Class II

  FDA 510(k) K120686 Active Cleared 4 Apr 2012

• Charnley Femoral Component

  Class II

  FDA 510(k) K760974 Active Cleared 16 Nov 1976

• Vanderbilt Pituitary Retractor

  Class I

  FDA 510(k) K761096 Active Cleared 30 Nov 1976

• Codman Isocool Bipolar Forceps

  Class II

  FDA 510(k) K083895 Active Cleared 23 Jun 2009

See all devices from Codman & Shurtleff, Inc. →