EMPOWERCTA INJECTOR SYSTEM - 9930

• 3 recalls, same reason

  • Terminated Z-0548-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004 ·on shared 510(k) K031571
  • Terminated Z-0550-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004 ·on shared 510(k) K031571
  • Terminated Z-0549-05 FDA Unclassified (pre-2012) ·initiated 3 Dec 2004 ·on shared 510(k) K031571

  Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.

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

510(k) Number

K031571 ↗

FDA Product Code

IZQ

Models / Variants

9930

9910

9825

Device Class

Class II

Regulation

21 CFR Part 870.1650

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. →