Support, Breathing Tube
Anesthesiology · 21 CFR 868.5280
Recent MDR events
150 adverse event reports on file
- NEO-FITJul 17, 2026InjuryCoopersurgical, Inc.1216677-2026-00067
- NEO-FITJul 17, 2026InjuryCoopersurgical, Inc.1216677-2026-00066
- NEO-FITJul 17, 2026InjuryCoopersurgical, Inc.1216677-2026-00065
- NEO-FITJul 14, 2026MalfunctionCoopersurgical, Inc.1216677-2026-00055
- NEO-FITApr 8, 2026MalfunctionCoopersurgical, Inc.1216677-2026-00030
- NEO-FITMar 23, 2026InjuryCoopersurgical, Inc.1216677-2026-00021
- NEO-FITMar 23, 2026InjuryCoopersurgical, Inc.1216677-2026-00023
- NEO-FITMar 23, 2026InjuryCoopersurgical, Inc.1216677-2026-00022
- NEO-FITJan 6, 2026MalfunctionCoopersurgical, Inc.1216677-2026-00001
- SUPPORT, BREATHING TUBENov 21, 2025InjuryUnknownMW5179238
Event type breakdown
Product problems
Reported product problem codes, most common first
Trend for “Detachment of Device or Device Component”
Recalls
2 recall events for this product code
- CooperSurgical, Inc.Open, ClassifiedNov 10, 2022
NEO-fit Neonatal Endotracheal Tube Grip, Part Number 42-2540
Firm has received 11 complaints involving a loose or detached metal clips, including 3 cases where the metal clip was ingested by the patient, and 3 cases where the metal clip was removed from the patient's mouth. In one case, the patient suffered a laceration to the throat.
Z-0223-2023 · View FDA record ↗ - Instrumentation Industries IncTerminatedJan 24, 2006
Flexible Support Arm Assembly. Breathing Tube Support. Catalog number BE 122-30
potential for the flexible tube portion of the assembly to become brittle and break
Z-0427-06 · View FDA record ↗
Registered firms
74 firms currently registered for this product code
Globalmed, Inc.
TRENTON Ontario, CA
Marpac, Inc.
ALBUQUERQUE, NM, US
Coopersurgical, Inc.
Trumbull, CT, US
Fisher & Paykel Healthcare, Inc.
IRVINE, CA, US
Draegerwerk Ag & Co. Kgaa
LUEBECK Schleswig-Holstein, DE
Dongguan Vincent Rehab Devices Company Limited
DONGGUAN Guangdong, CN
Westmed, Inc.
TUCSON, AZ, US
Isomedix Operations Inc.
SAN DIEGO, CA, US
Icu Medical Nederland B.v.
Wijchen Gelderland, NL
Zoll Medical Corporation
CHELMSFORD, MA, US
Lingxian Dongsheng Textile Co., Ltd.
Dezhou Shandong, CN
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Teleflex Medical Llc
Morrisville, NC, US
Orta Medical Ltd
TZUR YIGAL Central, IL
Atlas Medical Products Llc
Hialeah, FL, US
Resmed Pty Ltd.
BELLA VISTA New South Wales, AU
Meditera Tibbi Malzeme Sanayi Ve Ticaret A.s.
Tire Izmir, TR
S & Mohr America, S.a. De C.v.
ESTADO DE MEXICO Ciudad de Mexico, MX
Global Respiratory Solutions, Inc. (dba) Respiralogics
Reno, NV, US
Galemed Corp.
WU-JIA Yilan, TW
Flight Medical Innovations Ltd.
PETACH TIKVA Central, IL
Productos Urologos De Mexico S.a. De C.v.
MEXICALI Baja California, MX
Medical Devices (pvt) Ltd.
Sialkot Punjab, PK
Icu Medical Healthcare Manufacturing S.a. De C.v.
Tijuana, B.C. C.P. Baja California, MX
W.t. Farley, Inc.
Ladson, SC, US
510(k) clearances
19 clearances for this product code
- Custom Medical Specialties, Inc.Jan 27, 1995
K944988 · CUSTOM MEDICAL SUSPENSION STRAP
- B&B Medical Technologies, Inc.Oct 20, 1987
K873491 · BLOCK, BITE, INTUBATION
- Dale Medical Products, Inc.Feb 21, 1986
K860583 · DALE HEAD BAND ANESTHESIA CIRCUIT TUBE HOLDER 1315
- Vulcan Laboratories, Inc.Jul 19, 1985
K850924 · JEE FRAME (VENTILATOR CIRCUIT SUPPORT)
- Ackrad LaboratoriesFeb 14, 1985
K850309 · COMFIT PLUS ENDOTRACHEAL TUBE HOLDER & BITE BLOCK
- Exidyne, Inc.Mar 16, 1984
K840844 · ENDO-SECURE
- Tempe Biomedical, Inc.Jan 4, 1984
K834265 · TRACH MATE
- Ackrad LaboratoriesDec 29, 1983
K834089 · COMFIT