1ST Response Manual Resuscitator, Model 85XX

• 3 recalls, same reason

  • Terminated Z-0808-03 FDA Unclassified (pre-2012) ·initiated 15 Nov 2002
  • Terminated Z-0810-03 FDA Unclassified (pre-2012) ·initiated 15 Nov 2002
  • Terminated Z-0809-03 FDA Unclassified (pre-2012) ·initiated 15 Nov 2002

  Peep valve set at the highest level and could result in patient injury

510(k) Number

K014115 ↗

FDA Product Code

BTM

Device Class

Class II

Regulation

21 CFR Part 868.5915

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Trocar Catheter/Thoracic Catheter

  Class II

  FDA 510(k) K792202 Active Cleared 20 Nov 1979

• Thermovent 600, 1200, T, 02

  Class I

  FDA 510(k) K874597 Active Cleared 19 Jan 1988

• Blue Line Ultra Suctionaid Tracheostomy Tube

  Class II

  FDA 510(k) K030570 Active Cleared 17 Sep 2003

• Jet Ventilation Adaptor

  Not classified

  FDA 510(k) K842456 Active Cleared 6 Jul 1984

• 1ST Response Intermediate Manual Resuscitator

  Class II

  FDA 510(k) K023793 Active Cleared 11 Feb 2003

• Reinforced Silicone Tracheal Tube

  Class II

  FDA 510(k) K830352 Active Cleared 8 Mar 1983

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