Cannula, Nasal, Oxygen
Anesthesiology · 21 CFR 868.5340
Recent MDR events
1,767 adverse event reports on file
- N/AJul 22, 2026MalfunctionSalter Labs3004748541-2026-00138
- N/AJul 17, 2026InjurySalter Labs3004748541-2026-00120
- N/AJul 16, 2026MalfunctionSalter Labs3004748541-2026-00137
- LIBRE3 PLUSJul 13, 2026InjuryAbbott Diabetes Care Inc.MW5190665
- MEDLINE HUDSON RCIJul 9, 2026InjuryMedline Industries, Lp1417592-2026-04890
- PORTEX OXYGEN/AEROSOL TUBINGJul 7, 2026MalfunctionIcu Medical, Inc.3012307300-2026-07082
- SALTER O2 CANNULAJul 2, 2026MalfunctionSalter Labs3004748541-2026-00126
- SALTER O2 CANNULAJul 2, 2026MalfunctionSalter Labs3004748541-2026-00124
- SALTER O2 CANNULAJul 2, 2026MalfunctionSalter Labs3004748541-2026-00125
- N/AJun 12, 2026MalfunctionSalter Labs3004748541-2026-00112
Event type breakdown
Recalls
6 recall events for this product code
- Smiths Medical ASD Inc.TerminatedUnknown
smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style.
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Z-0071-2019 · View FDA record ↗ - Smiths Medical ASD Inc.TerminatedUnknown
smiths medical portex First Breath Adult Nasal Cannula, REF 001285, Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style.
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Z-0072-2019 · View FDA record ↗ - Smiths Medical ASD Inc.TerminatedUnknown
smiths medical portex First Breath Adult Nasal Cannula, REF 001289, Curved Flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style.
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Z-0073-2019 · View FDA record ↗ - Smiths Medical ASD Inc.TerminatedUnknown
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001292, with Gas Monitoring Line, 305 cm (10ft.) & Male Luer Connector, 213 cm (7ft.) Tubing, & Oxy
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Z-0074-2019 · View FDA record ↗ - Smiths Medical ASD Inc.TerminatedUnknown
smiths medical portex First Breath Nasal Oxygen Cannula, REF 001293, with Gas Monitoring Line, 305 cm (10ft.) & Female Luer Connector, 213 cm (7ft.) Tubing, & O
"Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.
Z-0075-2019 · View FDA record ↗ - Teleflex MedicalTerminatedUnknown
Hudson RCI, Pediatric Nasal Cannula, Non-Flared Prongs, Rx only,
Incorrect labeling; the box label indicates Pediatric, the product insert indicates an Adult device.
Z-2251-2017 · View FDA record ↗
Registered firms
289 firms currently registered for this product code
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Galemed (xiamen) Co., Ltd.
XIAMEN Fujian, CN
Zhejiang Medtec Medical Devices Co., Ltd
Hangzhou Zhejiang, CN
Productos Medline S.a. De C.v.
NUEVO LAREDO Tamaulipas, MX
Productos Urologos De Mexico S.a. De C.v.
MEXICALI Baja California, MX
Harsoria Healthcare Pvt. Ltd. (unit-2)
Baddi Himachal Pradesh, IN
Flexicare Lanka (pvt) Ltd
Bandaragama Western, LK
Flexicare Medical (dongguan) Ltd.
DONGGUAN CITY Guangdong, CN
Koo (shanghai) Industries Co., Ltd
Songjiang Shanghai, CN
Ningbo Hanyue Medical Technology Co.,ltd
CIXI CITY Zhejiang, CN
Responsive Respiratory Inc.
Saint Louis, MO, US
Haiyan Kangyuan Medical Instrument Co.,ltd.
JiaXing Zhejiang, CN
Masimo Corporation
Irvine, CA, US
Bioseal
PLACENTIA, CA, US
Salter Labs De Mexico De S.a. De C.v.
Chihuahua Mexico, MX
Galemed Corp.
WU-JIA Yilan, TW
Smc Medical Manufacturing Private Limited
BANGALORE Karnataka, IN
Dms Holdings, Inc.,
Waukegan, IL, US
Customed, Inc.
Fajardo, PR, US
Platinum Focus Group Ltd.
London London, City of, GB
Suru International Pvt Ltd
DAHANU Maharashtra, IN
Whr Hossinger Kunststofftechnik Gmbh
Roding Bavaria, DE
Ceva Logistics Netherlands Bv (venray)
Oostrum Limburgh, NL
Ad Supply Group Limited
London London, City of, GB
Nextphase Medical Devices Mexico Llc
TIJUANA Baja California, MX
510(k) clearances
42 clearances for this product code
- Hudson Respiratory Care, Inc.Jun 13, 2001
K011125 · NASAL CANNULA, WITH AND WITHOUT SUPPLY TUBING, AND OTHER SIMILAR NASAL CANNULA MANUFACTURED BY HRCI
- Puritas Health Care, Inc.Feb 3, 1994
K935533 · NASAL CANNULA
- Boston Pacific Medical, Inc.Mar 18, 1993
K922397 · 4 SURE TM NASAL OXYGEN CANNULA
- Alpine Specialties, Inc.Aug 14, 1992
K921496 · SKIN SAVER(TM) TUBING HOLDER, MODEL 1921 MODIFIED
- B & F Medical Products, Inc.Aug 11, 1992
K920573 · CANNULA NASAL OXYGEN
- Specialty Packaging Producs, Inc.Oct 18, 1991
K913421 · NASAL OXYGEN CANNULA, 81585, 81587 & 81589
- Alpine Specialties, Inc.Aug 20, 1991
K912197 · SKIN SAVER(TM) TUBING HOLDER, MODEL 467
- Salter LabsJul 24, 1991
K911740 · SALTER LABS NEONATAL NASAL OXYGEN CANNULA