Ultracell Nasal Packing

• 3 recalls, same reason

  • Terminated Z-0478-03 FDA Unclassified (pre-2012) ·initiated 8 Jan 2003
  • Terminated Z-0490-03 FDA Unclassified (pre-2012) ·initiated 8 Jan 2003
  • Terminated Z-0486-03 FDA Unclassified (pre-2012) ·initiated 8 Jan 2003

  Sterility of the device is compromised

510(k) Number

K920358 ↗

FDA Product Code

EMX

Device Class

Class I

Regulation

21 CFR Part 874.4100

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Anterior/Posterior Epistaxis Catheter

  Class I

  FDA 510(k) K945556 Active Cleared 18 Jan 1995

• Ultracell Instrument Wipe

  Class II

  FDA 510(k) K920353 Active Cleared 15 Sep 1992

• Nasal Splint

  Class I

  FDA 510(k) K945555 Active Cleared 19 Jan 1995

• Ophthalmic Sponges Open recall

  Class II

  FDA 510(k) K920354 Active Cleared 5 Aug 1992

• Ultracell Suction Sponge

  Class II

  FDA 510(k) K972633 Active Cleared 17 Dec 1997

• Epistaxis Balloon Catheter with Packing

  Class I

  FDA 510(k) K945554 Active Cleared 17 Feb 1995

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