E-Z-Em Pulsed Infusion System

• 3 recalls, same reason

  • Terminated Z-2260-2014 FDA Class II ·initiated 6 Aug 2014
  • Terminated Z-2261-2014 FDA Class II ·initiated 6 Aug 2014
  • Terminated Z-2262-2014 FDA Class II ·initiated 6 Aug 2014

  AngioDynamics became aware that Uni*Fuse Infusion Systems with Cooper Wire have the potential to contain an incorrect sized guidewire (too long).

• • Terminated Z-1707-2010 FDA Unclassified (pre-2012) ·initiated 17 May 2010

  This lot was packaged with the wrong occluding ball guidewire. The PulseSpray Catheter is 90 cm in length and requires a 109 cm occluding ball guidewire, however this lot was packaged with a 60 cm occluding ball guidewire.

510(k) Number

K905447 ↗

FDA Product Code

KRA

Device Class

Class II

Regulation

21 CFR Part 870.1210

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Enterocysis Tube W/Guide Wire & Connect

  Class II

  FDA 510(k) K840752 Active Cleared 2 May 1984

• E-Z-Em(R) Lufkin Biopsy Needles

  Class I

  FDA 510(k) K882601 Active Cleared 25 Jul 1988

• E-Z-Em Single Stick Puncture/Drainage

  Unclassified

  FDA 510(k) K842121 Active Cleared 1 Oct 1984

• Winged Infusion Set

  Class II

  FDA 510(k) K885264 Active Cleared 31 Jan 1989

• Bronchial Cytology Brush

  Not classified

  FDA 510(k) K853667 Active Cleared 18 Dec 1985

• Disposable Angiography Needles

  Class II

  FDA 510(k) K890209 Active Cleared 19 May 1989

See all devices from E-Z-Em, Inc. →