The Office of Prehospital Care
would like all EMS agencies to be advised of an urgent recall
of oxygen regulators with aluminum components in their high pressure
chambers. Due to concerns over safety, it is recommended that
all oxygen regulators meeting the recall criteria listed below
be immediately withdrawn from service. However, at the same time,
EMS agencies must continue to provide oxygen to patients
in accordance with New York State and WREMS treatment protocols.
Any EMS agency unable to fulfill these requirements should immediately
contact the Office of Prehospital at (716) 898-3525.
Effective immediately, Life Support
Products (LSP) in conjunction with the Food and Drug Administration
(FDA) will be conducting a product recall on all models and configurations
of LSP oxygen pressure regulators, regardless of their manufacture
date.
Effective immediately, Life Support Products (LSP) in conjunction with the Food and Drug Administration (FDA) will be conducting a product recall on all models and configurations of LSP oxygen pressure regulators, regardless of their manufacture date.
Over the past 5 years, FDA has received 16 reports of aluminum regulators used with oxygen cylinders burning or exploding. These incidents caused severe burns to 11 health care workers and patients. Many of the incidents occurred during emergency medical use or during routine equipment checkout. FDA and The National Institute for Occupational Safety and Health (NIOSH) believe that the aluminum in these regulators was a major factor in both the ignition and severity of the fires, although there are likely other contributing factors. Most of the reports received by FDA were for the Model L270 series of aluminum regulators manufactured by Life Support Products Inc. and Allied Healthcare Products Inc. (Earlier models were known as "270" regulators.)
The manufacturer, Allied Healthcare
Products has plans to cease the distribution of all regulators
containing aluminum and solely manufacture brass regulators.
In an effort to avoid potential product shortages, Allied is
instituting an interim measure wherein they will replace internal
high-pressure aluminum components with brass components in all
models manufactured. Because aluminum is lighter in weight than
steel, it is also used in oxygen cylinders. FDA and NIOSH believe
that aluminum cylinders can be used safely with brass regulators,
but that the combination of both oxygen regulators and cylinders
made from aluminum poses an increased fire hazard.
Trenton EMS Supplies, Inc. is a authorized LSP repair center
and along with Life Support Products, are committed to making
this recall as smooth and painless as possible. Due to the vast
number of regulators that will need updating, Trenton EMS Supplies
suggests that you contact us at your earliest convenience to
schedule your equipment for updating. Please call us @ 800-541-2922
or email trentonems@aol.com.
CLICK
HERE FOR ADDITIONAL FDA RECALL INFORMATION
CLICK
HERE FOR ADDITIONAL FDA RECALL INFORMATION