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Next Generation Portable Therapeutic Liquid Oxygen System

ESSEX INDUSTRIES, INC. · Model 50C-0083-1 · UDI-DI 10815363020032

BYJ

510(k) clearances

606

Adverse events (80 deaths)

Recalls

Facilities

Description

The Next Generation Portable Therapeutic Liquid Oxygen System (NPTLOX) is a low pressure portable 20.0 liter liquid oxygen storage and gaseous delivery system, capable of supplying up to 17,200 gaseous liters of oxygen at a maximum flow rate of 66 liters per minute at 50 psig. The unit features six quick disconnect outlet ports and comes with an accessory kit containing three 20 foot medical grade hoses, three flow control valves, three humidifier bottles and three quick disconnect adapters. The three flow control valves can deliver oxygen to three patients at flow rates from .5 to 15 liters per minute. The quick disconnect outlet ports can also supply 50 psi of oxygen to other medical devices or to oxygen regulators for additional patients. Weighing less than 150 pounds when full, the NPTLOX can be carried by two ground support personnel or mounted in an aircraft. The NPTLOX requires no external power and uses just two 9-Volt batteries for the quantity indicator. The system has been tested to MIL-STD-810.

Recalls

Date	Firm	Reason
2022-10-10	Caire, Inc.	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
2022-10-10	Caire, Inc.	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
2022-10-10	Caire, Inc.	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
2022-10-10	Caire, Inc.	An audit discovered some inconsistencies in weld penetration on the longitudinal weld seam on the inner bottle of the device on some of the units.
2007-10-23	Caire, Inc.	Moisture ingress into the electronic liquid level indicator may cause inaccurate liquid oxygen level readings. The oxygen could run out without the patient knowledge.
2006-10-04	Precision Medical, Inc.	Component assembly; The fill chuck is not assembled properly which may allow the device to come apart over time releasing its contents.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.