Infant Nasal Cannulae Assembly, Modified

• 2 recalls, same reason

  • Ongoing Z-3140-2026 FDA Class I ·initiated 11 Aug 2026
  • Ongoing Z-3139-2026 FDA Class I ·initiated 11 Aug 2026

  Potential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss of CPAP pressure, possibly reducing the effectiveness of treatment and lead to decreased oxygenation until connection is restored.

510(k) Number

K911780 ↗

FDA Product Code

BZD

Device Class

Class II

Regulation

21 CFR Part 868.5905

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Ackrad Endotracheal Tube Introducing Guide

  Class I

  FDA 510(k) K844557 Active Cleared 17 Dec 1984

• Nicos (Non-Invasive Cardiac Output System)

  Class I

  FDA 510(k) K904499 Active Cleared 1 Jul 1991

• Ackrad Bronchitrac

  Class I

  FDA 510(k) K822398 Active Cleared 4 Oct 1982

• Modified Infant Nasal Cannulae Assembly

  Class II

  FDA 510(k) K895031 Active Cleared 30 Oct 1989

• Ackrad Hysterosalpingography Set

  Class II

  FDA 510(k) K842231 Active Cleared 19 Sep 1984

• N-D0-Sure

  Class I

  FDA 510(k) K811185 Active Cleared 2 Jun 1981

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