Endotracheal Tube W/Holder & Connector

• • Ongoing Z-1289-2025 FDA Class I ·initiated 13 Feb 2025

  Affected devices have a smaller diameter than expected and may potentially result in inadequate ventilation to the patient. Patient may experience hypoxia, underdose, or cardiopulmonary collapse.

• 4 recalls, same reason

  • Terminated Z-2538-2014 FDA Class I ·initiated 7 Jul 2014
  • Terminated Z-2537-2014 FDA Class I ·initiated 7 Jul 2014
  • Terminated Z-2539-2014 FDA Class I ·initiated 7 Jul 2014
  • Terminated Z-2536-2014 FDA Class I ·initiated 7 Jul 2014

  The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.

• • Terminated Z-1641-2014 FDA Class I ·initiated 10 Apr 2014

  One lot of 3.0mm sized Connectors, Product Reorder No. 10035-05PS, Lot No. 2553426 were placed in packages labeled as size 3.5mm.

510(k) Number

K790312 ↗

FDA Product Code

BTR

Device Class

Class II

Regulation

21 CFR Part 868.5730

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

• Bi-Temp Temperature Monitor, Model TM-300D

  Class II

  FDA 510(k) K913082 Active Cleared 11 Dec 1991

• Endotracheal Tube Guide or Intubation Stylette

  Class II

  FDA 510(k) K854632 Active Cleared 3 Jan 1986

• Esophageal Stethoscope W/Thermocouple Type T

  Class II

  FDA 510(k) K864043 Active Cleared 15 Dec 1986

• Bi-Temp Temperature Monitor, Model Tm-400D

  Class II

  FDA 510(k) K912280 Active Cleared 17 Oct 1991

• Adap-Temp Temperature Sensor Adapter

  Class II

  FDA 510(k) K921190 Active Cleared 9 Mar 1993

• Myocardinal Temperature Sensor with Type 400 Serie

  Class II

  FDA 510(k) K920469 Active Cleared 11 Sep 1992

See all devices from Respiratory Support Products, Inc. →