C.P.A.P. Nasal Cannula

• 5 recalls, same reason

  • Terminated Z-0861-2007 FDA Unclassified (pre-2012) ·initiated 23 Mar 2007
  • Terminated Z-0859-2007 FDA Unclassified (pre-2012) ·initiated 23 Mar 2007
  • Terminated Z-0858-2007 FDA Unclassified (pre-2012) ·initiated 23 Mar 2007
  • Terminated Z-0860-2007 FDA Unclassified (pre-2012) ·initiated 23 Mar 2007
  • Terminated Z-0857-2007 FDA Unclassified (pre-2012) ·initiated 23 Mar 2007

  The luer-port in the expiratory elbow may be occluded, which interferes with a ventilator's ability to detect an accurate pressure reading.

510(k) Number

K871157 ↗

FDA Product Code

BZD

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Catalog No. 1755 1S0-Neb, a Filtered Nebulizer

  Class II

  FDA 510(k) K895231 Active Cleared 27 Oct 1989

• 5300 Percussor

  Class II

  FDA 510(k) K790675 Active Cleared 18 Apr 1979

• Ventilator Circuit

  Class I

  FDA 510(k) K812774 Active Cleared 23 Oct 1981

• Lightweight Plastic Cannula

  Class I

  FDA 510(k) K770487 Active Cleared 21 Mar 1977

• Lifesaver, Manual #5160

  Class II

  FDA 510(k) K780216 Active Cleared 14 Mar 1978

• 1160 Simple Isolation Valve & 1161 Filtered Valve

  Class II

  FDA 510(k) K870138 Active Cleared 6 Mar 1987

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