Wang/Mill-Rose Transbronchial Aspiration Needle

• 4 recalls, same reason

  • Terminated Z-0504-2013 FDA Class II ·initiated 20 Nov 2012
  • Terminated Z-0502-2013 FDA Class II ·initiated 20 Nov 2012
  • Terminated Z-0505-2013 FDA Class II ·initiated 20 Nov 2012
  • Terminated Z-0503-2013 FDA Class II ·initiated 20 Nov 2012

  ConMed received complaints from a user facility reporting that the WANG Transbronchial Aspiration Needles would not insert properly through the instrument channel of a 2.0 mm bronchoscope. If the device will not fit through the instrument channel of a 2.0 mm bronchoscope, it must be replaced with an alternate device and could result in minor inconvenience to the user.

510(k) Number

K914181 ↗

FDA Product Code

EOQ

Device Class

Class II

Regulation

21 CFR Part 874.4680

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

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• Thoracentisis Kit

  Class I

  FDA 510(k) K894326 Active Cleared 24 Jul 1989

• Endoscopic Injection Needle

  Class II

  FDA 510(k) K820973 Active Cleared 16 Apr 1982

See all devices from Mill-Rose Laboratory →